# plecanatide (trulance) has been approved for chronic constipation



## annie7 (Aug 16, 2002)

finally--a new C med has been approved!

http://finance.yahoo.com/news/synergy-pharmaceuticals-trulance-plecanatide-receives-233500128.html

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm537725.htm

from what i've read, it's supposed to cause less D than linzess does.

http://seekingalpha.com/article/3332385-does-synergy-pharmas-plecanatide-blow-away-the-competition

plecanatide should be available later this quarter:

https://www.thestreet.com/story/13960531/1/synergy-pharmaceuticals-secures-approval-for-linzess-competitor.html


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## irongrl (Oct 4, 2010)

That is good news! Thanks for posting!


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## annie7 (Aug 16, 2002)

thanks







. yes, it sure is good news. i was so happy read it. we desperately need effective C drugs that do not have bad side effects.


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## flossy (Dec 8, 2012)

Yes, Annie, thanks for posting this. Looking forward to seeing what people think of it.


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## joeyr2 (Jul 14, 2013)

Over 12 weeks, patients treated with TRULANCE achieved a significantly greater efficacy responder rate - the primary endpoint defined by the FDA for regulatory approval in CIC - in both studies compared to placebo (Study 1: 21% vs. 10%; Study 2: 21% vs. 13%, p<0.005 for both studies). Efficacy responders were defined as patients who had at least three complete spontaneous bowel movements (CSBMs) in a given week and an increase of at least one CSBM over baseline in the same week for at least nine weeks out of the 12-week period, including at least three of the last four weeks.

So despite the really really low standards for efficacy 21 vs 10 percent of people responded and 21 vs 13 in the two studies. This is really disappointing for what was probably the most hopeful drug in the pipeline. Our nightmare continues...


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## Nuffa (Sep 12, 2014)

Honestly? I for one am really happy that more and more ptions enter the market.bear in mind that there are diseases that have NO treatment options.


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## joeyr2 (Jul 14, 2013)

Nuffa said:


> Honestly? I for one am really happy that more and more ptions enter the market.bear in mind that there are diseases that have NO treatment options.


Yes I'm being honest, this drug has an admitted 79% failure rate. Of the 21% of the time it didnt completely fail it didnt completely succeed either. My hope was that this drug, would have lived up to expectations more so than this.

I too am really happy that more options are becoming available on the market, I see it as a very good thing for all of us.


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## Nuffa (Sep 12, 2014)

The failure rate stems from the fact that there are different causes for chronic constipation and ibs i think.


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## annie7 (Aug 16, 2002)

Nuffa said:


> The failure rate stems from the fact that there are different causes for chronic constipation and ibs i think.


i agree, Nuffa.


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## joeyr2 (Jul 14, 2013)

Nuffa said:


> The failure rate stems from the fact that there are different causes for chronic constipation and ibs i think.


I think we would be better off if the term IBS was eliminated from all medical textbooks. I imagine we all suffer from digestive issues for many different reasons and the cause of those reasons needs to be treated on an individual basis. The doctors and drug companies seem way too comfortable lumping us all in together and providing us with the same, mostly ineffective, treatments when we all have different causes for our problems.


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## annie7 (Aug 16, 2002)

agreed. for 30 years i was diagnosed with ibs-c. after doing some reading both here on the board and elsewhere, i began to suspect that i had more going on than ibs-c. i asked my gastro for some tests and then was correctly dx'd with colonic inertia, pelvic floor dysfunction, rectal hyposensitivity and megarectum. no wonder i needed dynamite to get anything out.


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## IBS-Cyndi (Jan 28, 2017)

One of the most prevalent causes of IBS is Candida overgrowth. Dr's never even think of treating that, because they deal in fixing symptoms instead of root causes, for the most part.


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## kevgo (Feb 1, 2017)

Clinically the efficacy rates are as good as Linzess with much less diarrhea. It will be considered best in class for CIC. IT's still a 10 month+ process to be approved for IBS-C unless your doctor prescribes off-label. You can check it out at www.trulance.com and sign-up to be notified when it is available. I'm interested to hear your experiences, and hopeful you all find the relief you are due.


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