Solvay submits NDA for cilansetron in USA

Solvay Pharmaceuticals, the US subsidiary of the like-named Belgiumcompany, has submitted a New Drug Application to the US Food and Drug Administration for cilansetron, an investigational product which is being studied for the treatment of irritable bowel syndrome with diarrhea predominance. The company says that it included an extensive Appropriate Use Plan as part of its submission.

"The filing of the cilansetron NDA in the USA 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," commented Harold Shlevin, Solvay Pharmaceuticals' chief executive.

The submission is based on efficacy and safety studies in more than 4,000 patients worldwide with IBS-D, the firm says. Cilansetron is a 5-HT3 receptor antagonist, which has been shown to inhibit 5-HT3 receptors, resulting in decreased gastrointestinal motility, secretion and sensation, thus improving symptoms of IBS-D in both men and women, Solvay points out, noting that current 5-HT3 therapies indicated for IBS are approved only for women.