# Patients speak out about Cilansetron



## Jeffrey Roberts

*The Irritable Bowel Syndrome Patient Action Group (IBSPAG) and IBS Association speak out about Cilansetron*Cilansetron is a much needed drug for the relief of diarrhea-predominant IBS.TORONTO, Ontario, April 1 - The Irritable Bowel Syndrome Patient Action Group (formerly the Lotronex and Zelnorm action groups) and IBS Association strongly support the use of the drug Cilansetron for the treatment of diarrhea-predominant Irritable Bowel Syndrome.Jeffrey Roberts, President and Founder of the Irritable Bowel Syndrome Association, and Coordinator of the Irritable Bowel Syndrome Patient Action Group (IBSPAG), commented, "The IBSPAG and the IBS Association began a campaign in March 2005 to inform the FDA as to how essential Cilansetron is for our groups. We are extremely disappointed with the FDA's not-approvable letter delivered to the manufacturer today for this drug and also for requesting further clinical studies which may ultimately delay access to what appears to be a safe drug, if prescribed correctly."Tim Phelan, a member of the Irritable Bowel Syndrome Patient Action Group has written to the FDA indicating "..living with IBS has been isolating and depressing and I am desperate to get my condition under control and get my life back. Cilansetron has the potential to dramatically improve my quality of life in a way that no other treatment has been able." Amy O'Sullivan, also a member of the Irritable Bowel Syndrome Patient Action Group, contacted the FDA and informed them "..having been in the clinical trial for Cilansetron for over a year, it worked better for me than Lotronex does. If I didn't have a great response to this medication I would have said so and dropped out of the trial as I had to drive over an hour each way and go through some uncomfortable tests (in order to be included in the study)." The Irritable Bowel Syndrome Patient Action Group and IBS Association will continue to educate the FDA as to what it is like to live with Irritable Bowel Syndrome and how essential Cilansetron is for sufferers of diarrhea-predominant IBS. If approved, Cilansetron is expected to be the only 5-HT3 therapy available to treat IBS-D in both men and women. Currently Lotronex, also a 5-HT3 type drug, is only available under a restricted-use plan for women. -------------------------------------------------------------------------Jeffrey D. Roberts, B.Sc.President & FounderIBS Association / IBS Self Help and Support GroupCoordinator Irritable Bowel Syndrome Patient Action Grouphttp://groups.yahoo.com/group/ibspag


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## BQ

Sigh....Thanks for posting this Jeff and speaking out for us. This is **so frustrating. What do they want??? If you know, does the FDA say what objections they have anywhere??? I mean can we read what their problem is with this drug? Do you know how long the "further clinical studies" will delay (hopefully) approval?I mean I read somewhere that Solvay is still hoping for a late 2005 release. You think that is realistic or optimistic on their part?I am slightly peeved. I guess I should know better, but I am disappointed.BQ


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## Jeffrey Roberts

I hope the FDA or the pharmaceutical sheds some light on the situation shortly. I think Solvay had plans to launch this drug now so they are probably as shocked as the rest of us that it will be delayed.After what we went through with getting Lotronex re-approved you would think that the FDA would realize that IBS-D patients and gastroenterologists are well aware of any risks associated with this drug and give more credit to everyone's ability to manage themselves.Jeff


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## BQ

Yup, One would think.... wouldn't one?Whoo boy...I hope this doesn't set it back too long. And I also hope that when it is released they don't make dispension of it glut the practices of GI specialists on a monthly basis. The vast majority of us and our Docs aren't idiots... someone should let the FDA in on that. Pahleeze.. lolBQ


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## 14397

What is going on, we need this drug! I hope it gets approved! Can't the FDA see what this drug would do to improve the quality of all "our" lives? This is so frustrating


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## 22061

I was involved in the Cilansetron drug study in Tacoma, WA, about 2 or 3 years ago! I was wondering what had happened to it. It worked great on me and I was very sad when the study was over as I knew what my life would go back to. I recently have found relief with Cholestyramine which my surgeon put me on after my gall bladder was removed. It is almost as good as Cilansetron, but not quite...


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## Luna

Hi Everybody,Long time no see.Is Cilansetron going to be difficult to get as Lotronex? I hope not.ciao Luna


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