Cilansetron NDA Submitted

Cilansetron (also known as Calmactin; Solvay Pharmaceuticals, Marietta, Ga),a selective serotonin (5-hydroxytryptamine; 5-HT) type 3 (5-HT3) receptor antagonist,has shown promising efficacy in patients with irritable bowel syndrome withdiarrhea (IBS-D). Results, however, from summary phase 3 data presented as anabstract and an oral presentation at the 105th Annual Meeting of the AmericanGastroenterological Association and Digestive Disease Week (held from May 15to 20, 2004, in New Orleans, La), raise questions regarding its safety, particularlyin women. In a 6-month, double-blind, placebo-controlled study of 792 patients(358 men and 434 women) presented by Marc Bradette, MD, and colleagues, 12%of patients in the cilansetron group (n = 395) experienced constipation, comparedwith 3% in the placebo group (n = 397). In addition, 3 cases (of 395) of suspectedischemic colitis were reported in the cilansetron group.

A comprehensive appropriate-use program accompanied the recent cilansetronNDA submission to the FDA.