Belviq (lorcaserin) filed with FDA for an extended release formulation in obesity- Eisai/Arena Pharma
Eisai and Arena Pharmaceuticals have announced that the FDA has accepted for filing the New Drug Application for an extended release formulation of Belviq (lorcaserin) for obese patients. If approved, the extended release formulation will offer patients a chronic weight management treatment in a once-daily dosing option.
The regulatory filing for the extended release formulation is based on the results of two Phase I registrational clinical 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. If approved, the extended release formulation is expected to be marketed as BELVIQ XR, which is the brand name conditionally approved by the FDA.
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