Lotronex alosetron hydrochloride regulatory update

FDA denied a Citizen's Petition from Nestle's Prometheus Laboratories Inc. unit asking the agency to provide guidance on how to develop a single, shared REMS. Prometheus filed the petition in June. The company is in discussions to develop a shared REMS for Lotronex alosetron for irritable bowel syndrome with generic company Roxane Laboratories Inc., part of Boehringer Ingelheim GmbH (Ingelheim, Germany). FDA also denied Prometheus' request for the agency to notify the company of waiver requests for the requirement for Lotronex's shared REMS. The companies are involved in a patent suit related to Lotronex; patents covering the serotonin (5-HT3) receptor antagonist expire in 2018. Prometheus has U.S. rights to Lotronex from GlaxoSmithKline.

Lotronex was withdrawn from the market in 2000 following reports of ischemic colitis and serious constipation complications. The drug was reapproved with new restrictions in 2002 and has a REMS with elements of safe use (ETASU). In July, FDA's Drug Safety and Risk Management Advisory Committee recommended modifying the REMS for Lotronex to ease the burden on pharmacists. ...