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Orexigen® Therapeutics COR-BMOD Study Published in the Journal Obesity
Date:8/3/2010

About Contrave

Contrave is an investigational combination therapy believed to address both physiological and behavioral drivers of obesity.  The two components of this combination therapy act in a complementary manner in the central nervous system.  The central pathways targeted by this treatment are involved in controlling the balance of food intake and metabolism, and regulating reward-based eating behavior.  In clinical trials, Contrave was shown to help obese patients initiate and sustain significant weight loss, improve important markers of cardiometabolic risk and increase ability to control eating.  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 and the Prescription Drug User Fee Act (PDUFA) action date has been set for January 31, 2011.

About the Contrave Clinical Development Program

All four trials in the COR Phase 3 program (COR-I, COR-II, COR-BMOD and COR-Diabetes) were 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. Secondary endpoints included multiple measures of cardiometabolic risk, quality of life, control of eating, and glycemic control.  Contrave was generally well tolerated.  The safety and tolerability profile of Contrave in the clinical development program was consistent with the safety profile of the constituent components, which have been in use for other indications for over 20 years.  The most frequent treatment-emergent adverse events in patients treated with Contrave were nausea, constipation, headache, vomiting and dizziness.  Treatment with
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SOURCE Orexigen Therapeutics, Inc.
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