Solvay Pharmaceuticals, Inc. 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 therapy or 5-HT therapies indicated for IBS are approved for women only.
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 is an international chemicals and pharmaceuticals group with headquarters in Brussels. It employs more than 30,000 people in 50 countries. In 2003 its consolidated sales amounted to EUR 7.6 billion generated by its three activity sectors: Chemicals, Plastics and Pharmaceuticals. Solvay is listed on the Euronext 100 index of top European companies.