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Orexigen® Therapeutics Announces Publication of COR-I Phase 3 Study of Contrave in Lancet
Date:7/29/2010

istory of use of these products."

Study Design

COR-I was a 56-week placebo-controlled, double-blind randomized trial enrolling patients whose body-mass index (BMI) was between 30-45 kg/m(2) for patients with uncomplicated obesity, or BMI 27-45 kg/m(2) with controlled hypertension or dyslipidemia, or both. 1742 patients were randomized to receive either Contrave32, Contrave16 (16mg naltrexone SR/360mg bupropion SR), or placebo in a 1:1:1 ratio. Thirty-four sites in the United States participated in the study.

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 bo
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SOURCE Orexigen Therapeutics, Inc.
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