Solvay Calmactin NDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Solvay'sCalmactin (cilansetron) could be the first irritable bowel syndrome therapy approved for use in men and women. Firm is requesting priority review for the July 1 NDA for treatment of diarrhea-predominant IBS in men and women. Novartis' constipation-predominant IBS agent Zelnorm (tegaserod) and GlaxoSmithKline's IBS-D therapy Lotronex (alosetron) are approved only for use in women. Novartis is pursuing Zelnorm approval for treatment of chronic constipation in both men and women. Pain Therapeutics' opioid antagonist naltrexone is in Phase III for both forms of IBS in men and women. Like Lotronex, cilansetron is a 5-HT3 antagonist. The NDA includes "an extensive appropriate use plan," Solvay says...