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Orexigen(R) Therapeutics Announces First of Four Phase 3 Trials of Contrave(R) Meets Co-Primary and Key Secondary Endpoints
Date:1/8/2009

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The overall discontinuation rate due to adverse events was 25.9% for patients taking Contrave versus 13.0% for those taking placebo. The most frequently observed adverse events leading to discontinuation for patients on study drug were nausea, urticaria (hives) and anxiety. The discontinuation rate due to nausea was 4.6%, an improvement over the 11.1% discontinuation rate seen in the Phase 2 trial (NB-201) which utilized the immediate release formulation of naltrexone as opposed to the proprietary SR formulation used in this trial. The most frequently observed treatment-emergent adverse events for patients on study drug were nausea, headache, constipation and dizziness.

"The results show that Contrave provided obese patients with clinically significant weight loss sustained over a one year period while also improving markers associated with cardiovascular disease," said Dr. Xavier Pi-Sunyer, a lead investigator for the study and Chief of Endocrinology at St. Luke's-Roosevelt Hospital/Professor of Medicine at Columbia University. "This study also showed that Contrave was generally well tolerated by patients, which is important in terms of patient compliance, especially since treating obesity is often a long-term endeavor."

The Company has scheduled a conference call at 5:00 pm Eastern Time to discuss further details from this trial. The live call may be accessed by calling 877-317-6701(domestic) 412-317-6701 (international); meeting code: 007 4510. The webcast can be accessed live on the investor relations section of the Company's web site at http://www.orexigen.com and will be archived for 14 days following the call. Additional findings will be presented at the JPMorgan Healthcare Conference on January 12, 2009 at 8:00 am (PST) in San Francisco, California.

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SOURCE Orexigen Therapeutics, Inc.
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