The FDA has approved the new drug application for Belviq XR (lorcaserin, Eisai Inc./Arena Pharmaceuticals) CIV extended-release 20-mg tablets. The new formulation is designed to offer patients a once-a-day dosing option.
Both the original 10-mg twice-daily formulation of Belviq and the newly approved 20-mg once-daily extended-release formulation are approved for use with a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a body mass index (BMI) of 30 kg/m2 or greater (obese) or a BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical condition, such as hypertension, hypercholesterolemia, or type-2 diabetes.
It is not known whether Belviq or Belviq XR, when taken with other prescription, over-the-counter, or herbal weight-loss products, is safe and effective. It is not known whether Belviq or Belviq XR changes a patient’s risk of heart problems, stroke, or death due to heart problems or stroke.
The bioequivalence and bioavailability of once-daily Belviq XR 20 mg compared with twice-daily Belviq 10 mg were based on two phase 1 registrational clinical trials in healthy adult subjects. The most common treatment-emergent adverse events were similar to those seen in phase 3 trials of Belviq 10 mg twice-daily.
Both Belviq and Belviq XR are federally controlled substances (CIV) because they may be abused or lead to drug dependence.
Source: Eisai; July 19, 2016.