Eiasi Inc. and Arena Pharmaceuticals Inc. this week announced the U.S. Food and Drug Administration (FDA) approval of Belviq XR (lorcaserin HCI).
A New Drug Application (NDA) was approved for the new formulation of the medication.
Belviq XR is an extended-release tablet that will be used in conjunction with a low-calorie diet and exercise plan to help overweight adults with a body mass index (BMI) of 30 or more, or with a BMI of 27 combined with high blood pressure, type 2 diabetes or another weight-related health condition.
"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," Director of the Comprehensive Weight Control Center at Weill Cornell Medicine and Principal Investigator of the BELVIQ clinical trials Dr. Louis J. Aronne said. "Having a once-daily treatment may offer an option for patients to stay on track to meet their weight loss goals."
The original weight-loss formulation, Belviq 10 mg, was taken twice daily to help patients lose weight. The extended-release Belviq XR 20 mg is a once-daily tablet.
"We're excited to offer this once-a-day option of lorcaserin," Eisai Inc. EVP, Neurology Business Group, Dr. Andrew Satlin said. "This option may provide another choice for patients who are overweight or obese and find it difficult to lose weight through diet and exercise alone. The development of this new formulation further underscores Eisai's ongoing commitment to help address the health care needs of this underserved population."