Solvay's irritable bowel syndrome therapy Calmactin (cilansetron) is "not approvable" March 23, one week ahead of the product's April 1 user fee date. FDA is requesting additional clinical trials to support an indication for treatment of IBS in both women and men. Solvay says it notified the agency March 30 of its intent to amend the cilansetron NDA. The decision follows the firm's February announcement that it no longer expected the Gastrointestinal Drugs Advisory Committee to review the 5-HT3 antagonist. The meeting was tentatively set for March 9 (1Pharmaceutical Approvals Monthly February 2005, p. 31)...

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...

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011