# Solvay Pharmaceuticals, Inc. submits NDA to the FDA for Cilansetron



## Jeffrey Roberts (Apr 15, 1987)

Press Release Source: Solvay Pharmaceuticals, Inc. Solvay Pharmaceuticals, Inc. submits New Drug Application to the United States Food and Drug Administration for cilansetron to treat Irritable Bowel Syndrome with diarrhea predominance in men and womenThursday July 1, 2:30 am ET MARIETTA, Ga., July 1 /PRNewswire/ -- Solvay Pharmaceuticals, Inc. announced today that it has submitted a new drug application (NDA) for cilansetron, an investigational product being studied for the treatment of irritable bowel syndrome with diarrhea predominance (IBS-D), to the FDA on June 30, 2004. The submission left the company's Marietta, Ga. facility on June 30, 2004, and is scheduled to arrive at the FDA on July 1, 2004. The company included an extensive Appropriate Use Plan as part of its submission. Per FDA guidance, the company expects a response from the FDA regarding acceptance of the application within the next 60 days."The filing of the cilansetron NDA in the United States represents a treatment advance that will address many of the unmet needs of people with IBS-D, improving the quality of life for men and women who struggle with this disease on a daily basis," said Dr. Harold Shlevin, Solvay Pharmaceuticals, Inc. President and CEO.The NDA submission is based on efficacy and safety studies in more than 4,000 patients worldwide with IBS-D. Cilansetron is a 5-HT3 receptor antagonist, which has been shown to inhibit 5-HT3 receptors, resulting in decreased GI motility, secretion, and sensation, thus improving symptoms of IBS-D in both men and women. Current 5-HT3 therapies indicated for IBS are approved for women only.Solvay Pharmaceuticals, Inc. (http://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. --------------------------------------------------------------------------------Source: Solvay Pharmaceuticals, Inc.


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## jjohnson (Apr 29, 2004)

Jeff,I was wondering if you might be able to answer a question about this press release. When it states that a decision must be made in 60 days, do you think that refers to the ultimate acceptance or rejection of the drug? Is this fast track approval? Any response would be much appreciated. Thanks.


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## Jeffrey Roberts (Apr 15, 1987)

My understanding is that within the 60 days the FDA only considers the NDA and whether to accept it. Afterwhich, the FDA has 10 months to respond to it, ie: approve or not approve the NDA. I do not know if this qualifies as fast track or not.Jeff


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## jjohnson (Apr 29, 2004)

Jeff,Thanks much for the clarification. I guess it looks like we're still going to have to wait awhile. Still, if it is approved, I think you might be able to take some amount of personal credit for it. I read about your hard work in getting Lotronex back on the market, and I think the FDA would probably be much more hostile to the idea of approving cilansetron if not for that.PS Sorry about posting my question twice


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