# FDA accepts New Drug Application for Prucalopride for CIC



## annie7 (Aug 16, 2002)

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

thanks so much to one of our members, wgbutler, for posting this information yesterday on the "drugs against C in the pipeline" thread. i thought i would start a topic on it here just to help make sure everybody sees it.

this is such good news! finally--it's about time! prucalopride has been available in other countries for several years now.

what makes prucalopride special is that it's a high affinity selective serotonin type 4 (5-HT4) receptor agonist--a prokinetic med that stimulates colonic peristalsis, increasing bowel motility. it's much different than amitiza, linzess and trulance. for those of us who remember zelnorm, it's similar to zelnom, but with a better safety profile.


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## wigglesmom (Dec 12, 2002)

Does this mean it's available now? Looking like it might not be available until Dec. 2018, but hoping I am wrong.


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## annie7 (Aug 16, 2002)

no, sorry--it's not available now. it's just been sent in for the fda to consider for approval. it should be approved in december and then it will become available during the first part of 2019. it's a long time to wait, i know. i wish the fda would fast-track it, like they did with linzess.

if you can get your doc to write you a script for it, you can buy it online at one of the online canadian pharmacies, like canadapharmacyonline.com. they have it but they need a script in order to send it to you. i've read posts from people who have done this. here is one of the threads on the ADMD motility disorders support board about that

https://www.inspire.com/groups/agmd-gi-motility/discussion/fda-accepts-new-drug-application-for-prucalopride-for-cic/

and :

https://www.canadapharmacyonline.com/DrugInfo.aspx?name=Resolor6820


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## wigglesmom (Dec 12, 2002)

Oh, thank you! I didn't know that.


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## annie7 (Aug 16, 2002)

you're welcome--good luck with everything.


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## dac122 (Feb 13, 2012)

I believe this drug is also available in Canada. Those with Docs willing to write scripts to Canada could get it. My last check showed it was expensive, well over $100 for 30 days supply.


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## annie7 (Aug 16, 2002)

yes, as i mentioned earlier, in my second post, as long as you have a script for it, you can get prucalopride from one of the online canadian pharmacies. and yes, it's quite expensive. you can check out that link i posted, where people discuss getting it from canada.


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## Zoltar (May 21, 2010)

Been available in the uk for ages, maybe couple of years. Linzess is more reliable for me personally, although i find prucalopride helps with trapped gas better.


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## dac122 (Feb 13, 2012)

Zoltar said:


> Been available in the uk for ages, maybe couple of years. Linzess is more reliable for me personally, although i find prucalopride helps with trapped gas better.


I am waiting here in the US for prucalopride to hit the market and am wondering what to expect. I think trapped gas is one of my problems.

Can you speak to any side effects of prucalopride or other things we should know?


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## joeyr2 (Jul 14, 2013)

annie7 said:


> 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
> 
> thanks so much to one of our members, wgbutler, for posting this information yesterday on the "drugs against C in the pipeline" thread. i thought i would start a topic on it here just to help make sure everybody sees it.
> 
> ...


@Annie7 Isn't a 5-HT4 receptor the same thing as linzess? Does this stuff pull fluids into the intestines like the osmotic laxatives that are currently available?


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## annie7 (Aug 16, 2002)

no, a 5-HT4 receptor agonist is not like linzess etc. it's a prokinetic med that stimulates peristalsis thus increasing bowel motility. it doesn't pull fluid into the colon like linzess, trulance, and amitiza do.

https://www.ncbi.nlm.nih.gov/pubmed/20408739


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## Vince Brazil (Oct 22, 2018)

Here in Brazil is avaliable pharma-grade.


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## wgbutler (Mar 15, 2018)

BOOM!

Apparently it's going to be called "Motegrity" in the United States. Kind of a weird name. I liked the name "Resolor" better, but whatever.

https://www.ptcommunity.com/wire/fda-approves-shire-s-motegrity-prucalopride-only-serotonin-4-receptor-agonist-adults-chronic

https://globenewswire.com/news-release/2018/12/17/1667784/0/en/FDA-approves-Shire-s-Motegrity-prucalopride-the-only-serotonin-4-receptor-agonist-for-adults-with-Chronic-Idiopathic-Constipation-CIC.html

https://www.streetinsider.com/Corporate+News/Shire+%28SHPG%29+Announces+FDA+approves+its+Motegrity+for+adults+with+CIC/14927835.html

https://www.nasdaq.com/article/shire-announces-fda-approval-for-motegrity--quick-facts-20181217-00296


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## annie7 (Aug 16, 2002)

thanks SO much for posting this wonderful news!!!! Hooray!!!!!!!!!!!!!!!!!!!!!!

(i wonder how that name--motegrity-- is pronounced???? )


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## wgbutler (Mar 15, 2018)

annie7 said:


> thanks SO much for posting this wonderful news!!!! Hooray!!!!!!!!!!!!!!!!!!!!!!
> 
> (i wonder how that name--motegrity-- is pronounced???? )


If I had to guess I'd think its pronounced in a similar way to the word "integrity", except with the syllable "mo" (rhyming with the word "row") at the beginning.

Now bring on Zelnorm, Tenapanor, Elobixibat, and the vibrating capsule, and other things.

We need lots of different options for this horrible condition!


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## annie7 (Aug 16, 2002)

yes--thanks-- you're probably right on the pronounciation. and yes, it sure is a weird name! i liked "resolor" better, too.

and thanks for all your helpful links.

yes we sure do need a lot of options. like you say--bring 'em on!


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## dac122 (Feb 13, 2012)

annie7 said:


> (i wonder how that name--motegrity-- is pronounced???? )


I am sure we will know soon enough as we get bombarded with commercials about it being the only pro-motility agent, warm little mascots and happy patients enjoying the sunset, resuming an active lifestyle.


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## wgbutler (Mar 15, 2018)

dac122 said:


> I am sure we will know soon enough as we get bombarded with commercials about it being the only pro-motility agent, warm little mascots and happy patients enjoying the sunset, resuming an active lifestyle.


That's hilarious! And you know that's exactly what is going to happen. In reality, if these companies displayed realistic commercials, they would show people running back and forth to the bathroom with uncontrollable D for hours. (But I realize that Motegrity/Prucalopride won't have this effect on most patients)

One time I took a Trulance pill and it actually did what these commercials say that these drugs do. I had one massive, extremely relieving experience in the bathroom and then it was all over and I didn't have to go to the bathroom any more that day. I was so amazed that I told the nurse practitioner at my GI's office about it when I saw her on my next GI appointment, and she remarked, "so that was just like the commercials!"

On another note, the constipation drug wars are about to begin:

https://www.fiercepharma.com/pharma/shire-gears-up-to-battle-allergan-new-constipation-drug-motegrity


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## dac122 (Feb 13, 2012)

wgbutler said:


> On another note, the constipation drug wars are about to begin:
> 
> https://www.fiercepharma.com/pharma/shire-gears-up-to-battle-allergan-new-constipation-drug-motegrity


May the safest, most effective drug with least side effects win!


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## nikki-m (Dec 14, 2018)

I am so happy to hear about this - I am actually seeing my gastroenterologist tomorrow and I plan to speak with him about it. I hope it becomes available soon!


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## annie7 (Aug 16, 2002)

highlights of prescribing information for Motegrity:

https://www.shirecontent.com/PI/PDFs/MOTEGRITY_USA_ENG.pdf


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## kc99 (Jun 7, 2007)

Thanks for posting! The full prescribing information starts on page 2. It's always helpful to see the pharmacokinetic information about this kind of thing (time to peak/half life/etc). I'm not a pharma expert, but my read of this is that it's the kind of drug that settles to a steady state level of sorts.

The section on the animal research is interesting, if those findings generalize to people. It suggests that all of the colon is stimulated -- not just one segment -- and there might be a cholinergic component to the effect.

I also like the phrase "high amplitude propagating contractions (HAPCs)." Always good to have a precise technical term to describe what I need a drug to accomplish. Probably better than making various analogies to dynamite and cannons and the like 

I am wondering if Shire might put up a website soon (maybe with coupons for free samples). I can't find anything yet.

Agreed that Motegrity is an odd name! I know that the process of naming a new drug can be very complicated -- there has to be a low risk of confusing it with any existing drug.


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## annie7 (Aug 16, 2002)

yes, i looked, too, to see if shire had a website up yet for motegrity but, like you, i couldn't find one, which is surprising. i imagine they'll put one up soon, since they want to be competetive with all the other pharmas selling C meds.


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## wgbutler (Mar 15, 2018)

Shire finally put up a website for Motegrity:

https://www.motegrityhcp.com/

The website says the drug is going to be available "1st half 2019". Ugh. I hope that means February or March instead of May or June. At any rate, at least the end is finally in sight.

Here's hoping it really helps people like me and others on this forum.


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## annie7 (Aug 16, 2002)

thanks so much for posting this!

and yes, i sure do hope this means sooner rather than later--we've been waiting for this med long enough already!

hope your fast is going well. take care.


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## stefan00790 (Jan 9, 2018)

Isn't this the same as here in Europe Resotrans ?! Because its the same chemical prucalopride ?!


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## annie7 (Aug 16, 2002)

yes, it is.


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## annie7 (Aug 16, 2002)

just updating this to say that Motegrity is now available!

https://www.ibsgroup.org/forums/topic/353338-motegrity-prucalopride-is-finally-available/


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