Orexigen Therapeutics Provides a Regulatory Update on Contrave NDA

Orexigen Therapeutics, Inc. OREX announced today that it recently met with the Food and Drug Administration regarding the New Drug Application for Contrave (naltrexone HCl/bupropion HCl) extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss. Orexigen sought the meeting to gain clarity on the approval deficiency stated in the Complete Response letter the Company received on January 31, 2011. The Complete Response letter requested that the Company conduct a randomized, double-blind, placebo-controlled trial of sufficient size and duration to demonstrate that the risk of major adverse cardiovascular events in overweight and obese subjects treated with Contrave does not adversely affect the drug's benefit-risk profile.