# Sticky  drugs against C in the pipeline--with updates



## Nuffa

I keep on searching the net for any news. I know there are one or two drugs in the pipeline but can't find any further information. Can someone provide me with links/information?


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## annie7

i don't know what's in the pipeline in germany, where you are. with the exception of the vibrating capsule, the following are in the usa pipeline, just google for more links and info on these---lots of info online.

that vibrating capsule in development in israel (not in usa pipeline AFAIK) :

http://www.usatoday.com/story/news/nation/2014/05/04/constipation-vibrating-capsule/8513473/

http://www.vibrantgastro.com/index.php?pid=3

velusetrag

http://www.theravance.com/gastrointestinal

http://en.wikipedia.org/wiki/Velusetrag

elobixibat

http://www.iffgd.org/site/news-events/news/industry-news/elobixibat

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4107709/

http://adisinsight.springer.com/drugs/800029037

plecanatide

http://www.synergypharma.com/drug-pipeline/plecanatide

tenapanor

http://www.prnewswire.com/news-releases/ardelyx-reports-positive-results-from-its-phase-2b-clinical-trial-evaluating-tenapanor-in-ibs-c-patients-277714701.html

http://www.ncbi.nlm.nih.gov/pubmed/26065434

relamorelin

http://www.prnewswire.com/news-releases/rhythm-presents-positive-phase-2-study-results-for-relamorelin-for-chronic-constipation-719659361.html

SYN-010

http://www.syntheticbiologics.com/2014-09-16-Synthetic-Biologics-Statin-Class-Candidate-for-Constipation-Predominant-Irritable-Bowel-Syndrome-Detailed-at-

Companys-Investor-Day

http://www.syntheticbiologics.com/product-pipeline/microbiome-focused-pipeline/syn-010

...and i'm still hoping prucalopride is in the usa pipeline somewhere...

hopefully someone else can add to this. i don't have a lot of time to dig around right now..maybe later.


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## flossy

annie7 said:


> i don't know what's in the pipeline in germany, where you are. with the exception of the vibrating capsule, the following are in the usa pipeline, just google for more links and info on these---lots of info online.
> 
> that vibrating capsule in development in israel (not in usa pipeline AFAIK) :
> 
> http://www.usatoday.com/story/news/nation/2014/05/04/constipation-vibrating-capsule/8513473/
> 
> Vibrating capsules?!? I could just see when it passes my prostrate, and me having having multi-orgasms, all while doing something like praying in church.
> 
> "What's that?!?"
> 
> "Ut-oh!" (Hey-now!) lol!!!


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## annie7

oh Flossy--too funny!









right after the news of this magic pill came out last year, steven colbert had a wildly funny sketch on his show about it. he called this his "number one story--or raher number "two story" that night and he advised that rather than use this pill, just put your cell phone on vibrate and put it up your butt lol and then call yourself....gives new meaning to the phrase "the call to stool"....

his sketch is in this show, right after the beginning (one minute 12 seconds into it)









http://thecolbertreport.cc.com/videos/p4t1a2/vibrant-constipation-pill


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## Nuffa

Thanks very much annie.i am currently trying the resolor. Helps, but it isn't the final solution for me. I keep on trying until i find a solution. How do you say annie? Hope springs eternal!!!


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## annie7

glad you are trying resolor and that it's helping a little but sorry it isn't the whole solution for you. if you're taking the 1 mg, try 2 mg dose.

I've read some people take resolor with miralax (movicol) or some other osmotic laxative or a stool softener or even magnesium (tablets or natural calm etc) and it works better for them that way. the osmotic helps soften things up and the resolor pushes it out.

I've also heard a few people say that resolor can take two or three weeks to get into your system and start to work fully...but, then, we're all so different in how meds work on us..

yes, it's a lot of experimentation and trial and error, isn't it. and oh yes--hope springs eternal! if it wasn't for hope--and faith--i'd have nothing. keeps me going.









keeping you in my prayers!


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## annie7

i'm going to try to keep this thread up-to-date and (thanks to kc99 for the information!) adding another med currently in the pipeline:

YKP10811--a serotonin 5 HT 4 receptor agonist

http://www.healio.com/gastroenterology/motility/news/online/%7B2e6c22df-43e4-42bd-b011-122a53cb3820%7D/ykp10811-improves-bowel-function-in-patients-with-functional-constipation

http://www.ncbi.nlm.nih.gov/pubmed/25148765

also--the vibrant capsule is now in clinical trails in the usa

https://clinicaltrials.gov/ct2/show/NCT02030756


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## Nuffa

Thanks so much annie!


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## annie7

thanks for starting this topic, Nuffa







. it's a good one to have on the board.


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## annie7

update on plecanatide. updated 6/2016

it's in phase 3 of the clinical trials now. synergy pharma filed an NDA for plecanatide in january 2016. if approved, they plan to launch it in 2017.

http://www.healio.com/gastroenterology/motility/news/online/%7Be71b448b-0510-487b-b9f7-cee513e1038c%7D/plecanatide-safely-treats-patients-with-chronic-idiopathic-constipation

http://www.synergypharma.com/research-and-development/plecanatide

http://www.businesswire.com/news/home/20160129005757/en/Synergy-Pharmaceuticals-Files-Drug-Application-Plecanatide-Chronic


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## annie7

update on plecanatide:

http://www.streetinsider.com/Corporate+News/Synergy+Pharma+(SGYP)+Will+Present+New+Plecanatide+Data+in+CIC,+IBS-C+at+ACG+Meeting/12078875.html


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## Nuffa

Thanks Annie!


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## annie7

thanks for starting this thread, Nuffa--great idea!


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## annie7

update on SYN-010

http://www.healio.com/gastroenterology/irritable-bowel-syndrome/news/online/%7Be28221ff-e168-436a-9152-163fbdfd811d%7D/syn-010-for-ibs-c-to-enter-phase-3-development-following-fda-meeting

http://www.syntheticbiologics.com/product-pipeline/microbiome-focused-pipeline/syn-010


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## annie7

update on tenapanor for IBS-C :

http://www.medpagetoday.com/MeetingCoverage/ACG/60931?xid=nl_mpt_DHE_2016-10-21&eun=g203337d0r&pos=1

http://awomanshealth.com/tenapanor-promising-in-the-treatment-of-irritable-bowel-syndrome/


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## Nuffa

Update on plecanatide ( sp?) it's coming soon. http://www.empr.com/drugs-in-the-pipeline/plecanatide-shows-promise-for-treating-ibs-with-constipation/article/578340/


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## annie7

thanks, Nuffa! this drug sounds very promising. there's always hope!


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## annie7

linzess news:

a new and supposedly better formula of linaclotide (linzess) is in the pipeline--linaclotide colonic release-1 (CR1). looks like it's supposed to be better for abdominal pain relief.

http://www.allergan.com/news/news/thomson-reuters/ironwood-and-allergan-report-topline-phase-iib-(1)

http://www.bizjournals.com/boston/news/2016/12/22/cambridges-ironwood-reports-positive-data-on.html

also -- a new low dose 72 mcg form of linzess:

http://globalpharmaupdate.com/fda-accepts-to-review-snda-for-72-mcg-dose-of-linaclotide-in-chronic-idiopathic-constipation/


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## annie7

plecanatide (trulance) has been approved!

http://www.ibsgroup.org/forums/topic/325666-plecanatide-trulance-has-been-approved/


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## flossy

I can't wait to see if people like it or not.


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## annie7

the new, lower dose of linzess--72mcg--has been approved by the FDA and should be available the first quarter of this year.

http://www.medscape.com/viewarticle/875013?src=wnl_edit_tpal&uac=15603EK


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## annie7

Trulance has just become available although not all pharmacies have it in yet.

the synergy pharma reps will also be distributing free one week sample packs to gastroenterologists for their patients to try.

there is a savings coupon for Trulance on the synergy website.

https://www.trulance.com/?&gclid=CKy9zJuS7dICFR2Hswod6fYBlA


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## annie7

update on tenapanor:

http://www.healio.com/gastroenterology/irritable-bowel-syndrome/news/online/%7B317008df-1ea4-42c0-9d22-f40e92f86092%7D/tenapanor-improves-symptoms-in-ibs-c


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## annie7

update on SYN -010

http://www.prnewswire.com/news-releases/synthetic-biologics-announces-allowance-of-key-us-patent-covering-syn-010-intended-for-the-novel-treatment-of-irritable-bowel-syndrome-with-constipation-ibs-c-300480127.html


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## annie7

update on elobixibat

https://globenewswire.com/news-release/2017/02/01/912872/0/en/Albireo-Announces-Submission-of-New-Drug-Application-for-Elobixibat-in-Japan.html

wish they submit an nda for it here in the usa....


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## annie7

update on tenapanor. looks like ardelyx will be submitting a new drug application for it with the fda in the second half of 2018.

https://www.healio.com/gastroenterology/irritable-bowel-syndrome/news/online/%7B92723300-4f61-42ac-8676-b6b3e7f5331c%7D/tenapanor-shows-better-results-in-second-pivotal-ibs-c-trial

tenapor helps reduce abdominal pain and visceral hypersensitivity as well as help with C.

https://www.streetinsider.com/Corporate+News/Ardelyx+%28ARDX%29+Reports+Data+from+Pre-Clinical+Studies+that+Tenapanor+Reduces+Pain+Caused+by+IBS-C+Through+Inhibition+of+TRPV-1+Signaling/13390753.html


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## annie7

update on tenapor.

ardelyx plans on submitting a new drug application to the fda during the second half of 2018.

https://www.prnewswire.com/news-releases/ardelyx-successfully-completes-t3mpo-3-safety-extension-study-of-tenapanor-for-ibs-c-300576499.html


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## wgbutler

Update on Prucalopride (Resolor)

https://globenewswire.com/news-release/2018/03/05/1415104/0/en/U-S-FDA-Accepts-New-Drug-Application-for-Prucalopride-SHP555-for-Chronic-Idiopathic-Constipation.html


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## annie7

thanks so much for posting this! that's wonderful news! Finally!!


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## stefan00790

Hey annie7 , is Fortrans powder for bowel preparation same thing as Miralax just a quick thought from you .?


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## annie7

i don't know--i've never heard of it. i googled it but google didn't tell me if it was the same as miralax or not. it sounds similar, but don't know if it's exactly the same. it does sound like it has PEG in it --not sure if it's PEG 3350 like mirlalax--but it also has other stuff in it as well. it sounds like it might be like GoLytly (has electrolytes in it). that's my guess.


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## SpaceNeedle09

stefan00790 said:


> Hey annie7 , is Fortrans powder for bowel preparation same thing as Miralax just a quick thought from you .?


Forlax is PEG 4000, a similar compound to Miralax PEG 3350. (polyethylene glycol)

I just ordered some PEG 4000 online, from a france based pharmacy. I dont tolerate Miralax/PEG 3350 well. I'm hoping PEG 4000 is better.

https://onlinelibrary.wiley.com/doi/full/10.1046/j.1365-2036.2003.01390.x

Comparison of efficacy and safety of two doses of two different polyethylene glycol‐based laxatives in the treatment of constipation


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## annie7

thanks for your information. good luck with the PEG 4000. hope it works for you. keep us posted.


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## wgbutler

Excellent news! Synthetic Biologics has FINALLY partnered up with someone to do phase 2 testing of SYN-010.

This is the drug that suppresses the methane producing activity of archeobactors, which is a cause of chronic constipation in IBS-C patients. Methane in the gut apparently slows down the transit of waste and the activity of the colon.

There are no side effects to taking this drug. No diarrhea, no abdominal pains, nothing. If your chronic constipation is caused by methane producing bugs in the gut, all this will do is is impair their ability to create methane and essentially cure you.

https://seekingalpha.com/news/3388305-synthetic-biologics-inks-deal-cedars-sinai-medical-center-clinical-study-synminus-010?app=1&dr=1#email_link


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## annie7

thanks so much for posting this! wonderful news!


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## wgbutler

Tenapanor was submitted to the FDA for final approval on September 13, 2018 and should be available early next year. It works by inhibiting the absorption of sodium in the gut, thereby increasing sodium levels in the large intestine and drawing more water into the large intestine. In that respect the mechanism is similar to Linzess and Trulance. Hopefully the side effects of diarrhea would be less severe. I'm not sure how it compares, but there is only one way to find out.

https://www.prnewswire.com/news-releases/ardelyx-submits-new-drug-application-for-us-marketing-authorization-of-tenapanor-for-ibs-c-to-us-food-and-drug-administration-300711834.html


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## annie7

thanks so much for posting this!

yes, hopefully this med won't cause D like linzess and trulance can.


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## annie7

zelnorm and prucalopride win fda panel's backing for constipation:

https://www.medpagetoday.com/gastroenterology/irritablebowelsyndrome/75810

hooray!! this is huge. finally we'll have not one but two C meds that increase peristalsis and motility--not like linzess, amitiza and trulance which only add fluid to the colon


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## scrapdizzle21

Any ideas how long til it could be available?

Sent from my SM-N960U using Tapatalk


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## annie7

so far i haven't read anything to indicate when zelnorm will be available.

according to this article, prucalopride should be approved by the fda around december 21. and then hopefully it'll be available --if not by late december-- by january or february.

https://globenewswir...nstipation.html

prucalopride is currently available in canada. if you can get your doc to write you a script for it, you can buy it from one of the canadian online pharmacies like canada pharmacy online.com it's quite expensive, though.

https://www.canadaph...ame=Resolor6820


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## wgbutler

This is awesome! Wow! In a short amount of time we should have three new drugs available for IBS-C and CIC (Tenapanor, Prucalopride, and Zelnorm). I'm glad that the market is finally responding to this problem with lots of different options!

Here's a link on Tenapanor:

https://www.mdedge.com/internalmedicinenews/article/167880/gastroenterology/tenapanor-shows-safety-efficacy-irritable-bowel

I have my eye on two other drugs on the horizon as well, Velusetrag and SYN-10.

Velusetrag is a drug like Prucalopride and Zelnorm, and has shown promising results for gastroperisis and constipation:

https://www.ncbi.nlm.nih.gov/pubmed/27269187

https://www.tandfonline.com/doi/abs/10.1080/13543784.2016.1195369?journalCode=ieid20

SYN-010 targets methane producing bacteria in the gut, preventing them from creating methane which is apparently a cause for slow intestinal transit and chronic constipation. It's currently going through a phase 2B clinical study at Cedars-Sinai Medical Center:

https://seekingalpha.com/news/3388305-synthetic-biologics-inks-deal-cedars-sinai-medical-center-clinical-study-synminus-010

It's probably going to be some time before these make it in but hopefully within the next 5 years.


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## annie7

yes, that's terrific that people will finally have some more options! Finally!!

i've been watching Velusetrag since they first started developing it because it's a selective 5-HT4 receptor agonist like zelnorm. i do hope they are still working on developing it it as a C med. all the reports i've read on it recently (in the last year) mentioned that they were developing it as a med for gastroparesis.


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## wgbutler

Here's are more articles discussing the FDA Panel approval of Zelnorm and Prucalopride:

Before it was approved:
https://www.medpagetoday.com/gastroenterology/irritablebowelsyndrome/75739

After it was approved:

https://www.medpagetoday.com/gastroenterology/irritablebowelsyndrome/75810


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## wgbutler

Elobixibat was approved for use in Japan earlier this year and is apparently doing very well. So hopefully it will make its way to the United States before too long.

https://www.thepharmaletter.com/article/elobixibat-approved-in-japan-for-the-treatment-of-chronic-constipation


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## annie7

well it looks like back in 2013 they were running clinical trials on it here but the study was terminated due to distribution issues:

https://clinicaltrials.gov/ct2/show/study/NCT01833065?show_locs=Y#locn

there was another study too:

https://clinicaltrials.gov/ct2/show/NCT01007123


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## annie7

there is also the vibrant vibrating capsule.

https://www.healio.com/gastroenterology/motility/news/online/%7B7cc7ed75-85d8-4dea-92f3-4dbc82ec6736%7D/vibrating-capsule-effective-for-chronic-idiopathic-constipation

https://www.ibsgroup.org/forums/topic/271842-what-about-the-vibrating-pill/?hl=%2Bvibrant+%2Bvibrating+%2Bcapsule#entry1187186


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## wgbutler

annie7 said:


> there is also the vibrant vibrating capsule.
> 
> https://www.healio.com/gastroenterology/motility/news/online/%7B7cc7ed75-85d8-4dea-92f3-4dbc82ec6736%7D/vibrating-capsule-effective-for-chronic-idiopathic-constipation
> 
> https://www.ibsgroup.org/forums/topic/271842-what-about-the-vibrating-pill/?hl=%2Bvibrant+%2Bvibrating+%2Bcapsule#entry1187186


The Vibrant Vibrating Capsule? That sounds like a magical artifact in a role playing game! And all I can say is WOW. This could be absolutely perfect. A device with no chemicals and NO SIDE EFFECTS that causes you to have normal peristalic waves! That's ingenious!

I just wonder how expensive this would be. Not knowing anything about it, it seems to me like it would be a small mechanical device with its own power source and would be quite expensive to produce in mass quantities. And obviously, it wouldn't be easily reusable (not that anyone would WANT to reuse it, that would be very gross!).

Stuff like this really gives me hope that by the time I'm an old man, this problem will just be a minor inconvenience well managed with modern medical therapies.

https://www.usatoday.com/story/news/nation/2014/05/04/constipation-vibrating-capsule/8513473/

https://www.digitaltrends.com/cool-tech/smart-pill-constipation/


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## annie7

yes, i would think that the vibrant capsule would be very expensive.


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## wgbutler

According to this meta analysis of various secretagogues, Tenapanor is the best at reducing bloating and has less adverse effects than linaclotide or trulance. Its probably not quite as efficacious, but it still may be plenty good:

https://www.ncbi.nlm.nih.gov/m/pubmed/30144426/


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## annie7

update on tenapanor:

https://www.prnewswire.com/news-releases/ardelyx-announces-fda-acceptance-of-the-filing-of-its-new-drug-application-for-tenapanor-for-the-treatment-of-patients-with-ibs-c-300748969.html


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## annie7

another update on tenapanor--scroll down to "Tenapanor for Irritable Bowel Syndrome with Constipation (IBS-C)

NDA accepted for review with PDUFA date September 12, 2019" :

https://www.ardelyx.com/what-we-do/


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## sjw596

I thought I'd give this thread a bump to ask whether someone who knows more about the current status of the new drugs awaiting approval could post a very brief summary of where each drug is in the pipeline. I've looked around, and it seems that some of the target dates have passed. Thanks!


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## wgbutler

sjw596 said:


> I thought I'd give this thread a bump to ask whether someone who knows more about the current status of the new drugs awaiting approval could post a very brief summary of where each drug is in the pipeline. I've looked around, and it seems that some of the target dates have passed. Thanks!


Well supposedly Motegrity is going to be released in the first half of this year. I'm so ticked off at Shire. The drug has been FDA approved since December 2018 and they haven't launched it yet. Seems like I've been waiting forever to try this drug out and I'm sick and tired of taking the secretagogues which give me horrible D. I don't understand why its taking so long considering that they have been selling this drug in Canada and Europe for years. Its not like this a brand new drug.

Tenapanor is due to be FDA reviewed in September of this year. It should easily get FDA approval and hopefully those guys won't drag their feet launching the new drug like Shire is doing with Motegrity.

And I read on this website: https://bottomlineinc.com/health/digestive/drug-free-constipation-cure-vibrating-pill that Vibrant is hoping to have their Vibrant capsule available in three years and are planning several phase 3 clinical trials this year, which I'm hoping to get in on.

I have no idea about Elobixibat or Velusetrag. I talked to someone on the forum who was in the Velustrag clinical trial and she said the drug completely cleaned her out within 15 minutes of taking it.

The Zelnorm reinstatement is in limbo, after passing out of the FDA GI committee last fall some group filed a protest against it. Haven't heard anything since.


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## annie7

thanks, wgbutler, for posting this. you're always such a good, reliable source for all the latest information.

wow--Velustrag really sounds impressive!


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## joeyr2

wgbutler said:


> Well supposedly Motegrity is going to be released in the first half of this year. I'm so ticked off at Shire. The drug has been FDA approved since December 2018 and they haven't launched it yet. Seems like I've been waiting forever to try this drug out and I'm sick and tired of taking the secretagogues which give me horrible D. I don't understand why its taking so long considering that they have been selling this drug in Canada and Europe for years. Its not like this a brand new drug.
> 
> Tenapanor is due to be FDA reviewed in September of this year. It should easily get FDA approval and hopefully those guys won't drag their feet launching the new drug like Shire is doing with Motegrity.
> 
> And I read on this website: https://bottomlineinc.com/health/digestive/drug-free-constipation-cure-vibrating-pill that Vibrant is hoping to have their Vibrant capsule available in three years and are planning several phase 3 clinical trials this year, which I'm hoping to get in on.
> 
> I have no idea about Elobixibat or Velusetrag. I talked to someone on the forum who was in the Velustrag clinical trial and she said the drug completely cleaned her out within 15 minutes of taking it.
> 
> The Zelnorm reinstatement is in limbo, after passing out of the FDA GI committee last fall some group filed a protest against it. Haven't heard anything since.


In the double-blind trials, one patient reported a suicide attempt 7 days after the end of treatment with MOTEGRITY 2 mg once daily; none were reported in patients on placebo. In the open-label trials, two patients reported a suicide attempt and another patient reported suicidal ideation. Completed suicide was reported in two patients, previously treated with MOTEGRITY 2 mg or 4 mg; both discontinued MOTEGRITY for at least one month prior to the event.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210166s000lbl.pdf


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## annie7

joeyr2 said:


> In the double-blind trials, one patient reported a suicide attempt 7 days after the end of treatment with MOTEGRITY 2 mg once daily; none were reported in patients on placebo. In the open-label trials, two patients reported a suicide attempt and another patient reported suicidal ideation. Completed suicide was reported in two patients, previously treated with MOTEGRITY 2 mg or 4 mg; both discontinued MOTEGRITY for at least one month prior to the event.
> 
> https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210166s000lbl.pdf


thanks for posting this and letting us know that it's something to be aware of.

i looked up the prescribing info for Resolor--the brand name for prucalopride in europe. it's been available for years. i thought it was kind of interesting that there aren't any warnings about suicide ideation etc in the prescribing information for Resolor .

https://www.ema.europa.eu/en/documents/product-information/resolor-epar-product-information_en.pdf

but then i did some more reading and found this article about suicide ideation with resolor. i imagine there are similar articles. too:

https://www.ncbi.nlm.nih.gov/pubmed/23889005

hopefully they're right about the "rarely" part.

there's other meds, such as antidepressants, that list suicide ideation as a possible side effect too...


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## joeyr2

annie7 said:


> thanks for posting this and letting us know that it's something to be aware of.
> 
> i looked up the prescribing info for Resolor--the brand name for prucalopride in europe. it's been available for years. i thought it was kind of interesting that there aren't any warnings about suicide ideation etc in the prescribing information for Resolor .
> 
> https://www.ema.europa.eu/en/documents/product-information/resolor-epar-product-information_en.pdf
> 
> but then i did some more reading and found this article about suicide ideation with resolor. i imagine there are similar articles. too:
> 
> https://www.ncbi.nlm.nih.gov/pubmed/23889005
> 
> hopefully they're right about the "rarely" part.
> 
> there's other meds, such as antidepressants, that list suicide ideation as a possible side effect too...


I figure if all they are willing to make is garbage meds that dont work for us they should at least not make us suicidal. We have enough to deal with.


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## wgbutler

joeyr2 said:


> I figure if all they are willing to make is garbage meds that dont work for us they should at least not make us suicidal. We have enough to deal with.


I have a hard time imagining how medications can make someone commit suicide. It's not like a pill can control your mind and actions and cause you do things you'd ordinarily not do. I've been taking anti-depressants for IBS pain management (it makes a noticeable difference in the abdominal and rectal pain) and I've never had any urges to commit suicide.

OTOH, I have been suicidal when my IBS symptoms have been really bad. I don't think I'd ever go through with it, my religious beliefs prohibit that and I have a family that depends on me. But it makes me wonder if the people who had suicidal thoughts were having them because of their GI symptoms and not because of the drug, because these symptoms can really drag you down emotionally when they are relentless and it looks like there is no relief in sight.


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## annie7

wgbutler said:


> OTOH, I have been suicidal when my IBS symptoms have been really bad. I don't think I'd ever go through with it, my religious beliefs prohibit that and I have a family that depends on me. But it makes me wonder if the people who had suicidal thoughts were having them because of their GI symptoms and not because of the drug, because these symptoms can really drag you down emotionally when they are relentless and it looks like there is no relief in sight.


agreed. well said.


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## wgbutler

Just a heads up. Shire has a new customer website for Motegrity:

https://www.motegrity.com

So maybe this means its close to being launched. I have an appointment with my GI in 3 weeks. Im crossing my fingers and hoping it launches before then.


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## annie7

hooray!!! they have a website now for Motegrity! progress!!

yes, fingers crossed that it's available before your GI appointment.

thanks so much for the update!


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## wgbutler

annie7 said:


> hooray!!! progress!!
> 
> yes, fingers crossed that it's available before your GI appointment.
> 
> thanks so much for the update!


If you go to the website: www.motegrity.com there is a customer service phone number (844) 447-2582.

And yes IT HAS OFFICIALLY LAUNCHED! You can get a prescription for it today.

Just to be 100% sure I called up my pharmacy (Express Scripts) and the CSR said it was available in 1mg and 2mg doses from them. I can get a 90 day supply for 53 dollars.

I'm not going to wait to see my GI in the middle of April. First thing tomorrow I'm going to schedule an appointment with my GP and try to get him to write me a prescription for it. If he says no then I will ask the GI in April. I don't care if the GI gets mad at me. I've been waiting forever to try this drug out and I don't want to wait any longer than I have to.


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## annie7

oh that's wonderful!!!! finally!!!!!!!!!!!!!!! what happy news!!! thanks so much for posting this!

Good! i'm so glad you decided to make an appointment with your GP and ask him to give you a script for it! hopfully he will--i don't see why not. my GP gave me a script for zelnorm back in the day.

and right--don't worry about your GI getting mad at you. IMO, if he's a good doctor and if he really cares about his patients, he shouldn't get mad. he should be happy for you that you are getting treatment. you've suffered way to much as it is.

keep us posted and good luck!


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## nikki-m

this is so exciting!!!! if the linzess fails (like trulance did), at least there is something else for me to try!


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## annie7

oh yes! this is huge! motegrity works so much more differently than linzess and trulance. motegrity doesn't just add water to the colon like they do. motegrity is prokinetic med that stimulates colonic peristalsis, increasing bowel motility.


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## wgbutler

Today I saw my urologist (this appointment was made weeks ago) at 7:30AM. I asked him if he would be willing to prescribe motegrity, he said no because that is not his area and its a brand new drug. I do want to say, however, that my urologist is completely awesome and if he had a twin brother who was a GI I would be in patient heaven.

Then I went to my general practitioner at 9:00AM. I specifically made an appointment with the doctor instead of one of his PAs. He's often been willing to prescribe things for me in the past and I figured I had a decent shot of getting a prescription if I got to see him. My heart sank when a PA walked through the door to the patient room, and of course, she said "no" and to ask my GI for a prescription to this medication.

Early next month I have an appointment with a colorectal surgeon. I'll go ahead and ask him as well, but if history is a guide he will say "no". Last year when I asked him for a prescription for Rifaxamin he said "no" and to try to get it from my GI.

Then on April 16th I have an appointment with the GI. He's already said "no" when I previously asked for a prescription for this so I could get it from Canada. Now that its available in the US he might be wiling to do it, but his modus operandi is to wait half a year or more after a drug is released before prescribing it to his patients, so its 50/50 at best. OTOH, I'm pretty sure that by the Fall at the latest he will be willing to write me a prescription for this.

The PA DID say she would be willing to get me a referral for another GI, but I'm hesitant to do that because that's a lottery ticket. I could get someone a whole lot worse than who I have now. The GI I have now is my 2nd one since having these problems again and the 1st one was a complete disaster.


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## annie7

Oh Noooooooooooo !!!!!!!!!

i am SO SORRY!!!!!!

that's just terrible!

i'm not surprised about the urologist but it was certainly worth a shot. but to have your GP's office play "bait and switch" with you--that's just not right. you're appointment was with the GP--- NOT the PA !!!! that's just not right!!! none of my doctor's offices have ever done that to me. your appointment is supposed to be with the doctor you made it with. if that doc for some reason isn't available that day, they should call you ahead if time and give you the option of seeing the PA (or another doc) but they shouldn't make you see him (her).

well, hopefully and fingers crossed your c/r surgeon will give you the script.

and i really think your GI's modus operandi is waaay too conservative especially considering that prucalopride has been available in other countries for years! you desperately need help. you've been suffering way too long. how can he not see this.

i'm so sorry. how very very frustrating and disappointing!


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## wgbutler

Thanks, Annie. One of the good things about having these problems again is that it has allowed me to meet people like you.

At the risk of talking off-topic, I would like to say that it's not all bad news. I told my urologist about my GI issues and asked him if they could be related to me having chronic prostatitus (the non-bacterial version), and he said that yes chronic constipation could aggravate and irritate my prostate. He said that one thing that might help is pelvic floor physical therapy, and he's going to have his office set me up with a physical therapist! I asked him if the therapist could also assist me with my chronic constipation, and he said yes they do all of that because its all close together anyway.

I think I'm still going to allow the colorectal surgeon to do those extra tests on me, but now there is nothing to gain but knowledge since I will already have access to a pelvic floor physical therapist.


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## annie7

oh, thanks for the kind words. and likewise--i'm glad to have meet people like you.









that's interesting what the urologist said. i know my C always made my bladder problems worse. and actually, based on what he said about chronic C aggravating and irritating the prostate--well, to my way of thinking, that might be a reason why he should prescribe motergrity to you--because it might help your prostate problems. but i can understand (i suppose) his retuctance to do this.

but anyway--that's great that he's sending sending you to a pelvic floor PT !!! wonderful news! these pelvic floor PTs are simply terrific---there's nothing they do not know. i asked mine tons of questions. and if it does turn out that you have pelvic floor problems or PFD, then the PT can help you with that as well, just like your urologist said. you'd be killing two birds with one stone, so to speak.

(and yes, it sure would be wonderful if your urologist had a twin brother who was a GI. he sounds like a terrific doc! )

and yes, that's a good idea to have your c/r surgeon go ahead with those tests. i was really glad i had mine (sitz marker, defecogram and anal manometry). they are great diagnostic tools and they give you a good idea of what's going on in there and specifically what your problems are.

good luck! keep us posted.


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## annie7

thanks to wgbutler for this update on elobixibat:

https://www.ibsgroup.org/forums/topic/353410-elobixibat/


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## annie7

thanks to wgbutler for this update on zelnorm:

https://www.ibsgroup.org/forums/topic/353694-zelnorm-re-approved-by-fda/


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## annie7

another update on zelnorm:

hopefully the pharma that has acquired zelnorm, alfasigma usa, will indeed make zelnorm available by prescription very soon--like the article says "in the coming weeks."

https://www.business...oduction-Market


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## annie7

just read this article.

apparently zelnorm (tegaserod) is now available here in the usa. finally!

https://www.biospace.com/article/releases/alfasigma-usa-announces-zelnorm-tegaserod-now-available-for-treatment-of-irritable-bowel-syndrome-with-constipation/


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## sjw596

I'm still not clear on why Zelnorm is female-only. I had taken it when it first came out, but actually quit because it caused D, a known side effect. Perhaps Alfasigma simply decided to include only women in its trials, and I can see that as they are more prone to CIC. In my case, if I wanted to try it again, my GI could request an insurance waiver for gender and age (I'm 69, but have an excellent health history with no heart issues-just a right hemicolectomy). My sense is that my doc would say "no." For the time being, I'm doing well with Motegrity - much better than with Linzess, Amitiza, and Trulance, which all worked for a while. Zelnorm does appear to have prokinetic properties, which may make it similar to Motegrity.


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## GJMody

When will synminus 010 be available for IBS patients


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## annie7

far as i know, SYN010 is still going through clinical trials and has not yet been approved in the usa. i have not yet read about an approval date for it. i don't know what's going on with it in india. as soon as i hear something, i'll post it in this topic.

as far as i know, this is the most recent post on it:

https://seekingalpha.com/news/3388305-synthetic-biologics-inks-deal-cedars-sinai-medical-center-clinical-study-synminus-010


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## Robert_Larsson

I can confirm what Annie posted, SYN-010 is still in Phase 2 clinical trials. I'm not sure if the drug is using the 505B1 or 505B2 development path. The latter which is applicable to already approved drugs which are reformulated (in this case lovastatin) usually takes less time to clear since safety and exposure data is already available at the FDA, so we could see a NDA sooner if the Phase 3 trial is shorter.

You can see how the Phase 2 study is progressing here: https://clinicaltrials.gov/ct2/show/NCT03763175

Estimated Study Completion Date : January 1, 2020


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## annie7

as always, thanks for the info! appreciate it!


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## Robert_Larsson

Thought I should add a potential new drug to the pipeline. This drug is not being evaluated for IBS specifically but is using a well studied mechanism in IBS (5HT-4 agonist) and is being investigated for Gastroparesis, Functional Dyspepsia and Chronic Constipation. This means the drug could potentially be used off-label to treat IBS-C patients in future.

Drug code: RQ-00000010

Company: RaQualia

Source: https://www.raqualia.com/product/


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## annie7

thanks again, Robert! as a 5HT-4 agonist, the drug sounds very promising.


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## annie7

Tenapanor (Ibsrela) was approved today. thank you WGButler for posting this:

https://www.ibsgroup.org/forums/topic/354938-tenapanor-ibsrella-fda-approved-today-september-12-2019/


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## Robert_Larsson

*TD-8954* is a selective 5-HT4 receptor agonist being investigated for potential use in the treatment of gastrointestinal motility disorders and has received U.S. Food and Drug Administration (FDA) Fast Track Designation.

Developers: Takeda; Theravance Biopharma

Source: https://www.theravance.com/programs/gastrointestinal

Adisinsight: https://adisinsight.springer.com/drugs/800031171


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## annie7

thanks, Robert! sounds promising! i'm glad they fast tracked it.


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## Robert_Larsson

Thought I should provide a little updated summary of which drugs currently are in the Pipeline for IBS-C, concerning only 505B1&505B2 filings at the FDA or corresponding agencies. Drugs mentioned above which are being investigated for chronic constipation, obstruction etc. are also included in the list but they would have to be used off-label. You can find information about ongoing trials below the Pipeline.

If you're aware of any other drugs under development please comment below. (Can't create a table in this forum so excuse the less beautiful columns)

Pipeline:

*Name/ dev.Code*----------*Company*--------------------------*Mechanism of Action* --------------------------------- *IBS sub-type*----------------------------*Status*------------------------*Ongoing Trial*--

Olorinab----------------Arena Pharmaceuticals--------------CB2 agonist---------------------------------------------------IBS-Pain----------------------------Phase 2B ongoing--------------NCT04043455----

Tenapanor-------------Ardelyx-----------------------------------NHE3 Inhibitor------------------------------------------------IBS-C--------------------------------FDA Approved as IBSRELA

SYN-010---------------Synthetic Biologics--------------------HMG-CoA reductase inhibitors--------------------------IBS-C---------------------------------Phase 2 ongoing----------------NCT03763175

Naronapride-----------Renexxion-------------------------------5-HT4 agonist------------------------------------------------IBS-C---------------------------------Phase 2

Blautix------------------4D Pharma PLC-----------------------Gastrointestinal microbiome modulators---------------IBS-Pain----------------------------Phase 2----------------------------NCT03721107

TD-8954---------------Theravance Biopharma--------------5-HT4 agonist-------------------------------------------------Motility disorders------------------Phase 2

RQ-00000010--------RaQualia---------------------------------5HT-4 agonist-------------------------------------------------Motility disorders------------------Phase 1

Drugs in ongoing trials

Olorinab (APD371), is a painkiller for all IBS sub-types (78% of patients suffer from abdominal pain). It is currently under development by Arena Pharmaceuticals and has now entered into another Phase 2 Clinical Trial (NCT04043455). Olorinab lessens pain by targeting the Cannabinoid Type 2 Receptor (CB2). The compound is peripherally acting and highly selective which means it lacks psychotropic effect (it doesn't make you high), which is quite important when targeting the Cannabinoid system. Last year Arena published results of an exploratory Phase 2a safety and efficacy trial, which showed a good safety profile and an average pain reduction of 82% in patients with Crohn's Disease in remission, suffering the same type of pain IBS patients do.

To participate in the Phase 2 study, click here to get further information from Arena or give them a call if you're in the US at 855-634-0290.

SYN-010 is a reformulation of the already approved drug Lovastatin, which is intended to reduce methane-production by certain microorganisms (M. smithii) to combat bloating, pain and constipation in patients with IBS-C. By using a delayed release formula it's designed to act primarily in the intestinal lumen while avoiding systemic absorption and thus enhancing its efficacy. SYN-010 is being developed by Synthetic Biologics and is currently in Phase 2 clinical trials (NCT03763175).

To participate in the Phase 2 study, click here to contact Synthetic Biologics.

Blautix is a single-strain human gut commensal bacteria which is being investigated for the treatment of IBS. By its distinct metabolism Blautix consumes gases which are known to cause bloating, abdominal pain and changes in bowel frequency. 4D Pharma is currently conducting a Phase 2 clinical trial (NCT03721107) to see if Blautix is effective in both IBS-C and IBS-D patients.

To participate in the Phase 2 study, click here to get more information.


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## annie7

thanks, Robert, for all your work on this--appreciate it! very informative.


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## MarciaDS

I have just signed up for a clinical trial in Boston (at Beth Israel Hospital) for the vibrating pill that aids in constipation.

I go for the first evaluation on January 6, but I passed the priliminary phone interview today.

I have to say, I am super excited! I found out about this by googling clinical trials for constipation in Massachusetts. I cannot find this on the clinical trial.gov website.

During the trial, you cannot take any prescription medicine or over the counter laxatives. However she said that if I don't produce a bowel movement in 3 consecutive days, I would be able to take a laxative as a "rescue." I found that kind of funny - 3 days without a bowel movement is totally normal for me - definitely not a scary situation that I would need "rescuing" from...

I will update with more info next month!!

This gives me hope - if anything I will have access to some GI doctors for free. The interviewer knows the doctor who gave me my colonoscopy on December 3, and said doctor is part of the study. They will examine me, do blood work, etc - maybe this can shed some light on my issues... fingers crossed ...


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## annie7

oh that's great! hope it helps you. good luck! and thanks for keeping us posted.


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## wgbutler

MarciaDS said:


> I have just signed up for a clinical trial in Boston (at Beth Israel Hospital) for the vibrating pill that aids in constipation.
> 
> I go for the first evaluation on January 6, but I passed the priliminary phone interview today.
> 
> I have to say, I am super excited! I found out about this by googling clinical trials for constipation in Massachusetts. I cannot find this on the clinical trial.gov website.
> 
> During the trial, you cannot take any prescription medicine or over the counter laxatives. However she said that if I don't produce a bowel movement in 3 consecutive days, I would be able to take a laxative as a "rescue." I found that kind of funny - 3 days without a bowel movement is totally normal for me - definitely not a scary situation that I would need "rescuing" from...
> 
> I will update with more info next month!!
> 
> This gives me hope - if anything I will have access to some GI doctors for free. The interviewer knows the doctor who gave me my colonoscopy on December 3, and said doctor is part of the study. They will examine me, do blood work, etc - maybe this can shed some light on my issues... fingers crossed ...


MarciaDS,

Any news on the vibrant capsule? I've been excited about this ever since I saw your message last month. Please report in with your experiences and what you think about it.

I tried to get in on a trial last year and I kept getting the runaround and never got in.


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## wgbutler

I called up the Gastroenterologist in Augusta, GA who is conducting the Vibrant trial this morning and they have accepted me into their trial if I want to do it. It's going to be tough because I have no idea if it will help me, or if I will even get the actual capsules instead of a placebo, and I can't take any of my usual stuff to help me go.

But I'm leaning towards doing it because its such a unique opportunity.


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## sjw596

This does seem like a promising treatment. I agree, though, that it could be challenging to take part in the trials. For instance, if it doesn't work, placebo or otherwise, how long can you endure being untreated? I'd find it difficult.


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## annie7

WGButler---that's great that you have been accepted into the vibrant clinical trail if you want to go ahead with it.

from what Marcia said, it sounds like you can take a rescue laxative if you don't have a bm for three consecutive days.

good luck if you do decide to go ahead with it. hope you get the real thing instead of a placebo! and hope it works for you.


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## Robert_Larsson

Just wanted to remind the forum that SYN-010 is due to conclude its phase 2 study this month and we can expect a press release soon as well. Let's hope it performed well!


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## annie7

thanks, Robert.

yes, let's hope that SYN-010 is an effective drug and will be put on the market soon.


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## sjw596

I'll be interested in learning how folks do with Tenapanor, especially those who've not had much luck with other prescription meds. It's availability seems somewhat limited at the moment, and cost usually is dependent on insurance coverage. My Motegrity+MoM is still working well, but I'd like to stay up to date on the new drugs that come out, as every one seems to work for limited time frames. Tenapanor seems more related to the Linzess type of drugs, as it adds liquid to the colon.


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## Robert_Larsson

*Yes that is right, Tenapanor belongs to the so called secretagogues drugs as opposed to prokinetics. There is pre-clinical evidence for some action on the TRPV1 receptor as well which facilitates some pain relief. Linzess pain relief works via cGMP instead. The question is rather how well a patient fits the specific mechanism, so it's probably best to stay on top of the pharmacology in case the G.I. is not sensitive to the fact that patients can be constipated for different reasons.*

*I'd also like to hear how well patients are responding to the treatment, however I want to stress the fact that there is considerable heterogeneity amongst IBS patients. This means of course that not only will we have people with non secretory issues primarily trying out the medication but also people with minor and major constipation. So I wouldn't be surprised if some will get diarrhea and some will still have an inadequate relief, just because the span of symptom severity is so large.*

*The statistics seem decent for an IBS study, we can be happy the Placebo group didn't take off above 25% so that's great:*

*"The primary endpoint, the combined responder rate for six of 12 weeks, showed that a greater proportion of tenapanor-treated patients compared to placebo-treated patients (36.5% vs. 23.7%, p<0.001) had at least a 30 percent reduction in abdominal pain and an increase of one or more complete spontaneous bowel movements (CSBM) in the same week for at least six of the 12 weeks of the treatment period."*

*Source: http://ir.ardelyx.com/news-releases/news-release-details/ardelyxs-pivotal-phase-3-study-tenapanor-ibs-c-hits-primary-and*


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## sjw596

Thanks for your comment. My issue primarily seems to be motility, so I'm hopeful that Motegrity will continue to work. It's not perfect, and I'm beyond the time frame studied in the trials. As I mentioned, I do need an osmotic adjunct, as prokinetics may need more fluid to make BMs easier to pass. Balancing motility and softening can be a little challenging. My theory is that peristalsis requires some bulk to be effective, and too much softness makes stool "squishy" and more difficult to move down and out. I've been through Linzess, Amitiza, and Trulance. I have chronic C and not IBS, nor do I have any pain. I've always had a daily BM, but suffered with them being incomplete or difficult to pass, so I'm more fortunate to many of the other list members. I'm looking forward to the "vibrating" pill, in case my Motegrity fails at some point. I'm unaware of any other prokinetics available now or in the works.


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## Robert_Larsson

I see, yes if there is no pain than that's clear. Motegrity is a 5HT-4 agonist like most prokinetics getting to market. I think you're right about the combination of the 2 drug classes as well, trial and error will have to keep guiding you.

Other 5HT-4 agonists in development: RQ-00000010, Naronapride and Velusertag.,


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## Robert_Larsson

Good news, Tenapanor was approved for IBS-C in Canada today:

https://www.globenewswire.com/news-release/2020/04/17/2017942/0/en/Knight-Therapeutics-Announces-Approval-of-IBSRELA-in-Canada.html


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## annie7

thanks, Robert, for the good news!


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## annie7

FDA approves Pizensy (lactitol) for chronic constipation.

https://www.drugtopics.com/new-products/fda-approves-pizensy-treatment-chronic-idiopathic-constipation-adults


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## Robert_Larsson

Bad news Ironwood discontinues the development of MD-7246 after it failed the Phase 2B clinical trial assessing abdominal pain in IBS-D. I post it here since it was supposed to be developed for IBS-C and IBS-M as well. It was a DR forumlation of Linzess (linaclotide) targeting specifically abdominal pain and not motility. Given the previously weak data I was not surprised. Let's hope other treatments are more successfull.

https://investor.ironwoodpharma.com/press-releases/press-release-details/2020/Ironwood-and-AbbVie-Report-Top-line-Phase-II-Data-for-MD-7246-in-Patients-with-Abdominal-Pain-Associated-with-Irritable-Bowel-Syndrome-with-Diarrhea-IBS-D/default.aspx


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## annie7

update on ibsrela (tenapanor) :

https://www.ibsgroup.org/forums/topic/357310-ibsrela-tenapanor-in-the-us/#entry1466532


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## wgbutler

I don't know if this has been posted yet, but here is another drug that was FDA approved this year for chronic ideopathic constipation. I haven't been able to find out if its been released to the general public yet. Information is scarce on it.

https://www.drugtopics.com/view/fda-approves-pizensy-treatment-chronic-idiopathic-constipation-adults


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## annie7

thanks. yes, i posted here about pizensy when it was approved but yes, you're right--not much info is available about it as of yet.


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## wgbutler

annie7 said:


> thanks. yes, i posted here about pizensy when it was approved but yes, you're right--not much info is available about it as of yet.


My sense of it is that it will be similar to the way lactulose works. I tried that out and it didn't do much for the C. Gave me horrible flatulence though, like eating 10 bowls of chili before bed. Totally not worth whatever little good it did for the C symptoms. My personal name for it was "flatulose".

I'd still like to try the pizensy out though as an experiment if it ever becomes available in prescription form.


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## annie7

oh yes, i've heard that lactulose can make people pretty gassy. like your name for it.









hopefully pizensy will be available soon.


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## Robert_Larsson

4D Pharma produces medicore results in Blautix Phase 2B trial. I made a walk thorugh of the trial in case you want to read more about the context.

SYN-010 fails Phase 2B interrim analysis.

Sad news, let's hope the second tenapanor inidcation can bring it to market.


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## annie7

thanks for the update, Robert--appreciate it!

and yes, very disappointing news about SYN-010.


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## Robert_Larsson

@annie and wgbutler, I assume you already know this however I thought I should leave it here for others just in case:

Tenapanor (Ibsrela) has received a PDUFA Goal Date - April 29, 2021 for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis. The drug has already been *approved for IBS-C* *in North America* however it does not seem to have been picked up for production as of yet. Following more positive results in another indication a potential approval could pave the way for its entry into the North American market, which would finally provide IBS-C patients with another treatment option.


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## annie7

thanks for posting this, Robert.


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## sjw596

I had posted this earlier, perhaps in another thread, but the manufacturer had told me that Tenapanor will not be distributed for IBS-C. Instead, it will me marketed to treat another (more lucrative I might add) condition. However, if something has changed, please let me know.


----------



## wgbutler

sjw596 said:


> I had posted this earlier, perhaps in another thread, but the manufacturer had told me that Tenapanor will not be distributed for IBS-C. Instead, it will me marketed to treat another (more lucrative I might add) condition. However, if something has changed, please let me know.


Right. They can make 4 times the money selling it to treat hyperphosphatemia (I assume this is some sort of chronic kidney disease problem) than they can selling it for chronic constipation. CKD drugs cost about 2000 per month, constipation drugs cost 500 per month.

I suppose if you are unlucky enough to have both CKD and chronic constipation, you will eventually be able to get the drug for the CKD condition and hopefully kill two birds with one stone.


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## wgbutler

So, a few years ago a drug Elobixibat was approved for use in Japan for chronic constipation, under the name Goofice.

Unfortunately, I have seen no evidence that this is going to be approved for the same problem in the United States. They are trying to approve it for other health conditions in the United States, however. I get the feeling this is the same scenario as Tenapanor, unfortunately, where no one wants to sell the drugs for constipation because they would have to sell it at a lower price than what they could get selling it for other health problems.

That being said, I found a website where you can order this from Japan. I don't know how reputable this site is, but there doesn't appear to be anything about a prescription being required. At any rate, the link is here:

https://bio-japan.net/goofice-tablets-japan


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## Robert_Larsson

sjw596 said:


> I had posted this earlier, perhaps in another thread, but the manufacturer had told me that Tenapanor will not be distributed for IBS-C. Instead, it will me marketed to treat another (more lucrative I might add) condition. However, if something has changed, please let me know.


I don't know exactly how things work in North America in detail, but over here in Europe this wouldn't matter in most countries. As long as the drug is approved and produced a clinician can prescribe it to you, even though the company is distributing it for other conditions. The majority of drugs used have never been approved for IBS specifically and are sold for other indications, clinical consensus governs as to which drugs you can prescribe to patients. The National Board of Health and Welfare might intervene and put certain restrictions on it as to which patients are allowed to use it depending on the price tag but generally that threshold is pretty high. What the company chooses to market the drug as is seen as a pure business decision. They have no recourse to deny the prescription anyway and so the state always has the final say.


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## annie7

thanks, Robert--i agree.

i've taken several meds off label--one of which was misoprostol, for my constipation.


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## sjw596

Yes, that would be true, and I'd give it a try. However, I'm not sure we can get it at the moment. My insurance company (Navitus) doesn't list it, and neither does Costco or Walgreen's. Perhaps someone on the forum will post back if he or she finds it.


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## Robert_Larsson

Hi everyone, new drug for the pipeline called* ANJ908*, indicated for functional constipation and IBS-C currently in Phase 2 clinical trials NCT04620161.
ANJ908 is an inhibitor of the diacylglycerol acyltransferase 1 enzyme.The inhibition of diacylglycerol acyltransferase 1 leads to higher levels of luminal fatty acids which stimulates intestinal movements and secretion at the same time, leading to increased motility. Anji Pharma is making the drug New Therapies & Drugs For Chronic Constipation & IBS-C

@annie7 , I'm so very sorry I haven't had time to update the pipeline but I will do it this month I promise!


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## annie7

thanks so much, Robert.

and you don't have to apologize. i really appreciate everything you do!


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## wgbutler

Update on Tenapanor / Ibsrela. It's apparently available to get in Canada now.



https://www.yahoo.com/entertainment/knight-therapeutics-announces-canadian-commercial-000400393.html



Also, the Vibrant capsule is getting closer.









Vibrant raises $7.5M for a drug-free mechanical pill to treat constipation


Vibrant, a medical technology company that’s developed a disposable vibrating pill to treat chronic constipation, today announced its Series E for $7.5 million. The company is based in Tel Aviv and is lead by Lior Ben-Tsur, a startup veteran. Since its founding in 2007, the company has raised a...




techcrunch.com


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## annie7

thanks so much, wgbutler, for this infomation! appreciate it!


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## Robert_Larsson

The 5-HT4 agonist PCS12852 is currently in development for motility disorders and preparing to go into phase 2 clinical trials. The lead indication *does not seem to be IBS-C* as there have already been previous approvals of other 5-HT4 agonists, but instead Processa Pharmaceuticals are looking at post-operative ileus, opioid induced constipation, chronic idiopathic constipation for now. As currently approved 5-HT4 agonists do have some safety concerns and dosing limitations, this is a potential future alternative to keep an eye on for IBS-C patients. 

Sorry for not fixing the treatments in development post but I struggle with making a sensible layout, anybody got some ideas?


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## wgbutler

Ibsrela (Tenapanor) finally getting released to market in 2 quarter 2022

After two+ years of being FDA approved. They are finally bringing it to market. I believe the reason why it took this long is because they wanted to market tenapanor to treat another disease that would have been more profitable. I'm not sure why they shifted gears, perhaps the other market didn't work out for them.

From what I've read, it's basically another secretatatogue like Linzess or Trulance. My hope is that it will be less severe and cause less D while still being an effective treatment for the C. 










Ardelyx Launching IBSRELA® Second Quarter of 2022


/PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a specialty biopharmaceutical company founded with a mission to discover, develop and commercialize innovative...




www.prnewswire.com


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## wgbutler

It's available. I'm going to schedule an appointment with my GIs and try to convince them to let me give it a try.









Ibsrela Now Available for Irritable Bowel Syndrome With Constipation


The approval was based on two phase 3 trials which evaluated Ibsrela in over 1200 adults with IBS-C.




www.empr.com


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## annie7

oh good! thanks for the update! hope one of your docs prescribes it for you. good luck and keep us posted. thanks!


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## wgbutler

annie7 said:


> oh good! thanks for the update! hope one of your docs prescribes it for you. good luck and keep us posted. thanks!



So I got one of my GIs to write the prescription today. Now the insurance is fighting paying for it because its a new drug and they have to do a prior authorization, so we'll see how long that takes to resolve. If I ever finally get the drug I'll try it out and post my experiences with it on this forum.


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## annie7

wgbutler said:


> So I got one of my GIs to write the prescription today. Now the insurance is fighting paying for it because its a new drug and they have to do a prior authorization, so we'll see how long that takes to resolve. If I ever finally get the drug I'll try it out and post my experiences with it on this forum.
> 
> View attachment 13843


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## annie7

goos luck. hope you get the scrfipt and it helps you!


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## wgbutler

annie7 said:


> goos luck. hope you get the scrfipt and it helps you!


After weeks of wrangling, the insurance agreed to cover the cost of the prescription. I now have a 30 day supply and I just took the first pill about half an hour ago. I'll write a review of my experiences with the drug in 3 or 4 days and compare it to other secretatogues like Linzess and Trulance. This is a great week to test it out because its a holiday week and I'm working from home.


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## annie7

good luck! hope it helps! and thanks for keeping us posted. fingers crossed for you!


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## wgbutler

annie7 said:


> good luck! hope it helps! and thanks for keeping us posted. fingers crossed for you!



So, just a report on the Ibsrela. It does work, sort of. What it does is give me a low grade case of D that lasts for 8-12 hours. I ended up giving up using it because the relief wasn't good enough to tolerate the low grade D for that length of time. Frankly I'd prefer to stick with Trulance, which gives me much more severe D but it wears off about 4 hours later and provides much more relief.


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## wgbutler

But here's another option that should be available in the near future.

FDA grants marketing authorization for Vibrant a new drug-free treatment for adults with chronic constipation - EIN Presswire (einnews.com)


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## annie7

thanks, wgbutler, for the update on Isbrela and also for the update on Vibrant--really do appreciate you keeping us in the loop about all this.

i do agree with you--- i think i would prefer to take Trulance instead of Isbrela for the reasons you mentioned.

and--yes--Vibrant. all i can say is what a novel approch to the problem of chronic constipation. it will be interesting to see what develops with this.

thanks again!


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## flossy

I came across this website a while back... For any person here where money is no object: 20 FMT capsules - $1,693.87. (Note: This doesn't include shipping costs. lol)






Buy Poop Pills + Where to Get Stool Transplant Donor FMT Capsules


Our FMT capsules are sourced from a single stool super donor who eats a strict diet to maintain an optimal gut microbiome. This is where to buy poop pills online & where to get a stool transplant in easy to take, freeze dried, oral FMT capsules.




fmtcapsules.com





Man, that is expensive and I would think I would need more than 20 pills to change my gut flora. Probably forty or sixty? I don't know.

I'm not recommending you try them, I just thought it was ... well, _interesting. _


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## annie7

yeah that is interesting. i wonder if this place is legit??


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## flossy

annie7 said:


> yeah that is interesting. i wonder if this place is legit??


I don't know if it's legit or not and the price is way too high for me to order.


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## annie7

yes, that's a pretty high price.


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## flossy

wgbutler said:


> But here's another option that should be available in the near future.
> 
> FDA grants marketing authorization for Vibrant a new drug-free treatment for adults with chronic constipation - EIN Presswire (einnews.com)


Thanks for posting this. Their website says something to the effect that their research shows that when the biological clock is not synchronized it may lead to constipation.............When the biological clock is resynchronized the natural bowel movement biorhythm is restored.

Well this is an interesting theory. I've always thought that most of us with chronic constipation have an imbalance of gut flora in our intestines. I've never heard of anyone having chronic constipation because their _biological clock_ is off. News to me! 

Sure I would try it to see if it works, but I am skeptical on the why we have it in the first place theory. Regardless, wouldn't it be great if it works? Yep.


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## wgbutler

flossy said:


> Thanks for posting this. Their website says something to the effect that their research shows that when the biological clock is not synchronized it may lead to constipation.............When the biological clock is resynchronized the natural bowel movement biorhythm is restored.
> 
> Well this is an interesting theory. I've always thought that most of us with chronic constipation have an imbalance of gut flora in our intestines. I've never heard of anyone having chronic constipation because their _biological clock_ is off. News to me!
> 
> Sure I would try it to see if it works, but I am skeptical on the why we have it in the first place theory. Regardless, wouldn't it be great if it works? Yep.



I got this today from a contact at Vibrant:

"William,

We received FDA clearance in August and preparing for the commercial launch in early 2023.

Vibrant will be available first in several select states, with gradual expansion to the rest of the US by the end of 2023.

Please follow our social media, and be the first to know when and where Vibrant will be available.

Thank you so much"


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