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-Contrave(R) Obesity Research Phase 3 Program Meets Co-Primary and Key Secondary Endpoints; Exceeds FDA Efficacy Benchmark for Obesity Treatments-
Date:7/20/2009

erence, visceral fat, HDL cholesterol and triglycerides.
  • Additional analyses indicate that Contrave patients experienced reductions in the frequency and strength of food cravings and an increased ability to control their eating compared to placebo.
  • Contrave was generally well tolerated by patients across the COR Phase 3 program. The COR program data continue to be analyzed and compiled for submission to relevant scientific conferences, peer-reviewed journals and regulatory agencies.
  • "The successful completion of the COR Phase 3 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 CEO 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."

    (1) Contrave32 is a proprietary fixed-dose combination of bupropion SR 360mg/naltrexone SR 32mg. References to Contrave16 and Contrave48 relate to combinations containing naltrexone SR 16mg or naltrexone SR 48mg, respectively.

    Trial Design and Results of COR Phase 3 Trials

    All Phase 3 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. These endpoints were analyzed using intent-to-treat (ITT) last observation carried forward (LOCF) of all randomized patients who had at least one post-baseline observation while on study drug. Secondary endpoints included multiple measures of cardiometabolic risk, food cravings and eating control, as well as HbA1c in the COR Diabetes trial. Patients were randomized to re
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    SOURCE Orexigen Therapeutics, Inc.
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