FDA schedules Advisory Committee meeting to review Orexigen's Contrave NDA

Jun 24 2010

Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced that the U.S. Food and Drug Administration (FDA) has tentatively scheduled a Division of Metabolic and Endocrine Drug Products Advisory Committee meeting on December 7, 2010 to review the Company's New Drug Application (NDA) for Contrave® (naltrexone sustained release (SR)/bupropion SR) for the treatment of obesity.  On June 1, 2010, the Company announced that the FDA accepted the Contrave NDA filing for review.  On June 17, 2010, the Company announced that the Prescription Drug User Fee Act (PDUFA) action date has been set for January 31, 2011.

"We look forward to the opportunity to present the findings from the Contrave clinical program and demonstrate the potential value of Contrave in treating patients with obesity," said Michael Narachi, President and CEO of Orexigen.  "We believe that weight loss and weight maintenance are achievable goals in the treatment of obesity and its co-morbidities, and that if approved, Contrave will provide physicians and patients an important therapeutic option to address this unmet need."   

Confirmation and details of the meeting will be published in the Federal Register about six to eight weeks prior to the scheduled meeting date.  The Federal Register notice will be available at the following Website: http://www.fda.gov/RegulatoryInformation/Dockets/FR/default.htm.