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FDA recently approved the New Drug Application (NDA) for (lorcaserin HCl) CIV extended-release 20 mg tablets (Belviq XR, Eisai Inc. and Arena Pharmaceuticals), a once-a day dosing option for chronic weight management.
FDA recently approved the New Drug Application (NDA) for (lorcaserin HCl) CIV extended-release 20 mg tablets (Belviq XR, Eisai Inc. and Arena Pharmaceuticals), a once-a-day dosing option for chronic weight management.
Belviq XR is expected to be available in fall, 2016, and its price will be determined then.
Belviq and Belviq XR are the only selective 5-HT 2C receptor agonists approved for chronic weight management along with diet and exercise, according to a spokesperson for Eisai.
“With approximately two-thirds of the U.S. population living with extra weight or obesity, there is a significant and growing need to address chronic weight management,” said Louis J. Aronne, MD, director of the Comprehensive Weight Control Center at Weill Cornell Medicine, physician at New York-Presbyterian/Weill Cornell Medical Center and Principal Investigator of the Belviq clinical trials. “Having a once-daily treatment may offer an option for patients to stay on track to meet their weight loss goals.”
However, despite the entry of multiple new FDA-approved prescription weight loss products including Belviq XR, “there continues to be a significant coverage gap for medications that treat obesity,” the spokesperson said. “Unfortunately, most insurance carriers continue to exclude prescription obesity medications from their standard benefit, making these options cost prohibitive for many Americans in need of treatment. Eisai is committed to continuing to work with payers of all types to understand current practices, biases and beliefs related to attitudes regarding weight management options, including pharmaceuticals.”
Belviq is proven to be slowly absorbed in the body and lasts throughout the day, according to Eisai. Both the original 10 mg twice-daily formulation of Belviq and 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 BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical condition, such as high blood pressure, high cholesterol, or type 2 diabetes.
The bioequivalence and bioavailability of once-daily Belviq XR 20 mg compared with twice-daily Belviq 10 mg was based on two phase 1 registrational clinical trials among healthy adult subjects. The most common treatment-emergent adverse events were similar to those seen in the phase 3 clinical trials of Belviq 10 mg twice-daily.
However, it is not known if 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 if Belviq or Belviq XR changes your risk of heart problems, stroke, or death due to heart problems or stroke,” Eisai said.