Arena, Eisai Says FDA Accepts NDA For Lorcaserin Extended Release Formulation

(RTTNews) - Arena Pharmaceuticals, Inc. (ARNA) and Eisai Inc. announced Monday that the U.S. FDA has accepted for filing the New Drug Application or NDA for an extended release formulation of lorcaserin.

If approved, the extended release formulation, which will offer patients a chronic weight management treatment in a once-daily dosing option, will be marketed as BELVIQ XR, the brand name conditionally approved by the FDA.

The regulatory filing is based on the results of two Phase 1 registrational trials evaluating bioequivalence of a once-daily, 20 mg extended release formulation of lorcaserin, as compared to the currently approved, twice-daily 10 mg immediate release formulation.

Lorcaserin is believed to decrease food consumption and promote satiety by selectively activating the serotonin 2C receptors in the brain. The extended release formulation of lorcaserin is investigational and not approved by any regulatory agency.