Orexigen Obesity Drug Hits Phase III Endpoints

Orexigen Therapeutics reported that all three remaining Phase III trials of Contrave, a combo of bupropion SR (a.k.a. Wellbutrin) and naltrexone SR, met their co-primary endpoints for the treatment of obesity. The results from the successfully completed Contrave Obesity Research, or COR, program of more than 4,500 patients exceed the FDA categorical efficacy benchmark for clinically significant weight loss, supporting the company’s plan to file an NDA with the FDA in the first half of 2010.

“The successful completion of the COR Phase III program is a major milestone for Orexigen, and the results demonstrate the potential for Contrave to help patients in their battle against obesity,” said Mike Narachi, president and chief executive officer of Orexigen. “These results highlight the benefits of Contrave, a novel combination that was specifically designed to address the behavior and reward pathways in the brain that impact one’s ability to initiate and sustain weight loss.”

All Phase III trials in the COR program were 56 week, randomized, double-blind, placebo-controlled trials. The co-primary endpoints were the proportion of patients achieving at least 5% weight loss and percent change in body weight compared to placebo.