Posted by Michael Wonder on 20 Jul 2016
U.S. FDA approves Belviq XR, a once-daily formulation of lorcaserin for chronic weight management
19 July 2016 - Eisai Co., Ltd. announced today that the U.S. FDA has approved a new drug application for Belviq XR, a once-daily formulation of lorcaserin hydrochloride (Belviq) for chronic weight management.
Belviq XR is a sustained release formulation which enables once-daily treatment, increasing the convenience of administration compared to twice-daily Belviq tablets. This approval was based on clinical data that confirmed bioequivalence of once-daily 20 mg Belviq XR with twice-daily 10 mg Belviq tablets. Eisai believes Belviq XR will offer patients the potential benefits of the full FDA approved 20 mg dose in a simple once daily tablet.
Belviq XR is scheduled for launch in autumn 2016.
This approval was obtained by Arena Pharmaceuticals, whom Eisai and its U.S. subsidiary Eisai Inc. have an exclusive licensing agreement with to commercialize lorcaserin hydrochloride.
