# Cilansetron NDA Filing Accepted for Priority Review by the FDA for IBS-D



## Jeffrey Roberts (Apr 15, 1987)

http://www.solvaypharmaceuticals-us.com/ne...1385-2-0,00.htm Cilansetron NDA Filing Accepted for Priority Review by the FDA for the Treatment of Irritable Bowel Syndrome with Diarrhea Predominance Marietta, GA. (September 1, 2004) ï¿½ Solvay Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted priority review of the company's New Drug Application (NDA) for cilansetron, an investigational 5-HT3 receptor antagonist, being studied for the treatment of irritable bowel syndrome with diarrhea predominance (IBS-D) in men and women. Products assigned for priority review by the FDA are those that appear to represent a potential therapeutic advance over existing therapies. The company is seeking approval to manufacture and market cilansetron for the treatment of IBS-D in the United States."We are pleased to announce that the cilansetron NDA has been accepted by the FDA for priority review," said Dr. Harold Shlevin, Solvay Pharmaceuticals, Inc. President and CEO. "We believe our clinical data demonstrate that cilansetron is safe and efficacious for the treatment of IBS-D in men and women, improving their quality of life. If granted FDA approval, we believe cilansetron will provide a significant treatment advance to address unmet needs of IBS-D sufferers." The clinical data supporting the cilansetron NDA are based on efficacy and safety studies in approximately 4000 patients worldwide with IBS-D. The use of cilansetron in clinical trials resulted in significant relief of overall IBS symptoms, abdominal pain/discomfort, and abnormal bowel habits in men and women. Current 5-HT therapies indicated for IBS are approved for women only. Solvay Pharmaceuticalsï¿½ NDA submission includes a comprehensive appropriate use program based on collaboration with physicians, pharmacists, patients, and risk minimization experts. The cilansetron Appropriate Use Program (AUP) features an array of educational tools that the company intends to discuss with the FDA.It is estimated that as many as 30-45 million men and women suffer with IBS in North America, with approximately one-third from IBS-D. Missing work, school or leisure activities due to IBS symptoms is common among sufferers. According to a study published in Gastroenterology in 2002, the total costs of IBS in the United States have been estimated at approximately $21 billion.Solvay Pharmaceuticals, Inc. (www.solvaypharmaceuticals-us.com) of Marietta, Georgia (USA), is a research-driven pharmaceutical company that seeks to fulfill unmet medical needs in the therapeutic areas of cardiology, gastroenterology, mental health, women's health and a select group of specialized markets including men's health, antiemetics and hematology. It is a part of the global Solvay Pharmaceuticals organization whose core activities consist of discovering, developing and manufacturing medicines for human use. Solvay Pharmaceuticals, Inc. is a subsidiary corporation of the worldwide Solvay Group of chemical and pharmaceutical companies headquartered in Brussels, Belgium.Contact:Gabrielle BraswellSolvay Pharmaceuticals, Inc.(770) 578-5637Kelly TylerKetchum(202) 835-7279


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## SpAsMaN* (May 11, 2002)

Do you think it can help other type of IBS?Probably no,stupid question.


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## Jeffrey Roberts (Apr 15, 1987)

No. It is strictly for diarrhea predominant IBS.Jeff


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## jason haberland (Jun 28, 2004)

That is great news! I've been suffering with IBS-D for a long time and this seems like promising news! Has this drug been out before and does anyone know how it helps with D?


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## Jeffrey Roberts (Apr 15, 1987)

Please visit the *5-HT3 forum* for more information about Cilansetron.Jeff


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## JuliaNYC (Apr 20, 2000)

I think this is good news. I'm amazed no one is commenting on it.


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## Nath (Jan 5, 1999)

I think another IBS-D drug getting priority review means the FDA is starting to take IBS seriously.Hopefully some competition for Lotronex will drive the prices down a bit for the people who have to pay out of their own pocket for it, and make it easier for people to get on their insurance.


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## jjohnson (Apr 29, 2004)

I am also very pleased at the FDA's decision. Since priority review is designated to drugs that are an improvement over currently available treatments, I don't think that the FDA could have reasonably decided otherwise, given the fact that Lotronex is barely "available," and just about everything else scarcely qualifies as "treatment". I agree that the FDA may now be taking IBS more seriously, and I think that this may be due in no small part to all the people who worked to get Lotronex back and made similar petitions on behalf of Zelnorm, which I'm pleased to hear has been approved for its new indication. Seems like our luck may be starting to change.


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## Stay Strong (Nov 22, 1999)

I don't post messages that often, but frequently check in to see whatï¿½s new. For the past 2 years I've been eagerly awaiting the approval of Cilansetron and really hope it works better for men then Lotronex does. I've been on Remeron for close to 4 years and it's helped, but definitely is not a cure. The one thing I find odd is that you don't really hear anything about the drug from people who may have been in a trial. I might not be looking hard enough, or people might not be aware of what drug they took. It just seemed like there was more of a buzz about Lotronex before it was approved.


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## lionala17 (Aug 29, 2003)

With FDA looking at approval of this drug, how long do you thing it will be before release? Hope it won't be as restricted as lotronex. Lotronex has helped me but my poor son has problems to and it would great if he had an option for taking something.....


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## kath139 (Sep 9, 2001)

According to the NHS Drugzone website we in the United Kingdom should be getting the launch of Cilansetron in November of this year.


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## jjohnson (Apr 29, 2004)

kath139,Is there any chance you could post a link to that NHS website? Even though I'm in the US, I'm very much interested in seeing this drug bring the greatest benefit to the greatest number of people the world over. To my knowledge, the drug has not yet been approved by the MHRA, but a report of some kind was issued by something called the London New Drugs Group, which I understand is somehow affiliated with the NHS but I'm not sure if it is an advisory committee or what.


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## kath139 (Sep 9, 2001)

I'm not sure how to do links but I will have a go. http://www.druginfozone.org/home/default.aspx when that page comes up type in Cilansetron in the search for box. I hope that works for you


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## cadreaming (Jul 25, 2002)

I was on Lotronex but had to stop because of IC. Does anyone know if I'll be able to take Cilansetron? Does it work the same as Lotronex?Thanks,Maria


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## jjohnson (Apr 29, 2004)

Hi Maria,I'm sorry to hear that you have suffered from this unfortunate side effect from a drug that has helped so many people. As for your question, I know the two drugs are chemically fairly similar. Still, drugs in general seem to work in such mysterious ways that I don't think anyone could say for certain whether you'd be at a high risk for side effects from cilansetron, if and when, God willing, it is approved. I believe that cilansetron is a somewhat weaker 5-HT3 antagonist than Lotronex, which would explain the lower rate of constipation in the clinical trials, for instance. (Someone please correct me if I'm wrong. I don't claim to be any sort of authority on this subject.) And if you survived Lotronex without any permanent harm, you might want to give it a try, although I'm sure any doctor would want you to be closely monitored on the new drug as an added precaution. Hope this helps.


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## jason haberland (Jun 28, 2004)

Jeff, based on this news about Colansetron, when could we expect it to come out and be able to get this prescribed? This sounds like a major breakthrough for people suffering from IBS


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## Karla (Sep 28, 2004)

I have talked to the Representative at Solvay Pharmaceuticals and the FDA approval/denial should come shortly after Jan. 1 2005. In the meantime I have gone onto the FDA website and written a letter to the Executive Secretary for the Gastrointestinal Drugs Advisory Committee letting him know how truly important new drugs are to IBS-D suffers. Other letters to him can't hurt...here is the web address for Thomas H. Perezperezt###cder.fda.gov


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## lclements (Nov 9, 2004)

I have been suffering from mostly IBS-D (sometimes the meds turn it to IBS-C for a few days) for years but only just recently have gotten a 100% confirmed diagnosis... but I cant find anyone to help me with my questions or give me any options or help... any suggestions? I am very frustrated! Thanks


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