Eisai Inc. and Arena Pharmaceuticals, Inc. have announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for an extended release formulation of lorcaserin. If approved, the extended release formulation will offer patients a chronic weight management treatment in a once-daily dosing option.
Lorcaserin (sold under the brand name BELVIQ®) is currently approved as an adjunct to 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. It is not known if BELVIQ is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products, nor is it known if BELVIQ changes the risk of heart problems or stroke, or death due to heart problems or stroke.
"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. "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 regulatory filing for the extended release formulation is based on the results of two Phase 1 registrational clinical trials evaluating bioequivalence of a once-daily, 20 mg extended release formulation of lorcaserin, as compared to the currently approved, twice-daily 10 mg immediate release formulation. If approved, the extended release formulation is expected to be marketed as BELVIQ XR®, which is the brand name conditionally approved by the FDA.
"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."
Lorcaserin is believed to decrease food consumption and promote satiety by selectively activating the serotonin 2C receptors in the brain.
The extended release formulation of lorcaserin is investigational and not approved by any regulatory agency.