Eisai Inc. and Arena Pharmaceuticals, Inc. recently announced that the U.S. Food and Drug Administration has accepted filing of a New Drug Application (NDA) for an extended release formulation of lorcaserin (BELVIQ), a serotonin 2C receptor agonist for oral administration used for chronic weight management.
If the new Lorcaserin formulation receives FDA approval, the extended release option will offer patients the drug in a once-per-day dosing option. The drug is currently approved as an add-on to a low-calorie diet and increased physical activity for chronic weight management in adults with a body mass index (BMI) of 30 kg/m2 or greater (considered obese), or BMI of 27 kg/m2or greater (considered overweight) with at least one weight-related medical problem, including high cholesterol, high blood pressure, or type 2 diabetes.
The efficacy and safety of the formulation remains unknown when taken in combination with other drugs, or herbal weight loss products. It is also unknown if the formulation alters the risk of death, stroke, or heart problems.
“The filing of this application by the FDA means they have made a threshold determination that it is sufficiently complete to permit a substantive review,” said Craig M. Audet, Ph.D., Arena’s Senior Vice President of Operations & Head of Global Regulatory Affairs in a recent press release. “This extended release formulation has the potential to offer patients once-daily dosing of lorcaserin, which can be an important addition to their chronic weight management plan.”
The regulation filing for NDA of the formulation’s extended release is based on data from two Phase 1 registrational clinical trials assessing the bioequivalence of 20 mg, once per day extended release formulation of the composite, in comparison to the currently approved, 10 mg, twice per day immediate release formulation. If the extended release formulation receives FDA approval, it will be available on the market under the name BELVIQ XR®.
“The dramatic rise in obesity has major consequences for public health,” said Frank Ciriello, President, Eisai Global Neurology Business Unit and Established Products. “If approved, this once-a-day option will provide another choice for appropriate patients who find it difficult to lose weight through diet and exercise alone.”
The composite is thought to reduce food intake and promote satiety by selectively activating the brain serotonin 2C receptors.