CalmactinTreatment for Irritable Bowel Syndrome
FDA Requests Further Data on Cilansetron, Solvay's Proposed Treatment for Irritable Bowel Syndrome with Diarrhea Predominance (IBS-D)
MARIETTA, Ga., April 01, 2005 -- As announced last week during a corporate press conference in Brussels, Solvay Pharmaceuticals, Inc. has received a letter from the Food and Drug Administration (FDA) on its new drug application (NDA) for cilansetron, a novel drug submitted to the Agency for the treatment of irritable bowel syndrome with diarrhea predominance (IBS-D) in both men and women. The "not-approvable" action letter requests additional clinical trials. Solvay Pharmaceuticals, Inc. is examining its options and will discuss future steps with the FDA and other experts for this product in the U.S.
As many as 30-45 million North American adults have symptoms of IBS -- approximately one-third from IBS-D. The common symptoms of IBS-D are diarrhea, abdominal pain/discomfort, and fecal urgency. IBS has a significant negative impact on the quality of life for the many men and women who suffer from this condition, causing lost days of work and interfering with home- based, social and leisure activities.
About Solvay Pharmaceuticals, Inc.
Solvay Pharmaceuticals, Inc. 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. 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.
For more information, please visit www.solvaypharmaceuticals-us.com
Posted: April 2005
- Cilansetron; Solvay Pharmaceuticals Suspends Registration Activites in the U.S., While Discussions in Europe Continue - November 29, 2005
- Solvay Pharmaceuticals, Inc. Announces 90-Day Extension of FDA Review of the New Drug Application for Cilansetron for the Treatment of Irritable Bowel Syndrome with Diarrhea Predominance (IBS-D) - December 20, 2004
- Cilansetron NDA Filing Accepted for Priority Review by the FDA for the Treatment of Irritable Bowel Syndrome with Diarrhea Predominance - September 1, 2004
- Solvay Pharmaceuticals, Inc. Submits New Drug Application to the United States Food and Drug Administration for Cilansetron toTreat Irritable Bowel Syndrome with Diarrhea Predominance in Men and Women - July 1, 2004