Eisai and Arena announced that the Food and Drug Administration (FDA) has approved Belviq XR (lorcaserin HCl extended-release tablets).
Belviq XR, a CIV controlled substance, is indicated 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 ≥30kg/m2 (obese) or BMI of ≥27kg/m2 (overweight) with at least one weight-related medical condition (eg, high blood pressure, high cholesterol, type 2 diabetes).
Data from two Phase 1 registrational clinical trials in healthy adult participants supported the bioequivalence and bioavailability of once-daily Belviq XR 20mg with twice-daily Belviq 10mg. The most common treatment-emergent adverse events were similar to those observed in the Phase 3 clinical trials of Belviq 10mg.
Both Belviq and Belviq XR are serotonin 2C receptor agonists that are believed to decrease food consumption and promote satiety by selectively activating 5-HT2C receptors on anorexigenic pro-opiomelanocortin neurons located in the hypothalamus.
Belviq XR will be available in 20mg strength extended-release tablets in 30-count bottles. It is anticipated to launch in the Fall of 2016. Belviq is already available as 10mg strength tablets in 60-count bottles.
For more information call (888) 274-2378 or visit BelviqXR.com.