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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

Completers Contrave Placebo p-value** Contrave Placebo p-value** Weight Loss (%) 9.3% 5.1% <0.001 11.5% 7.3% <0.001 Weight Loss (lbs) 20.3 lbs 11.0 lbs <0.001 25.0 lbs 16.0 lbs <0.001 greater than or equal to 5% weight loss 66.4% 42.5% <0.001 80.4% 60.4% <0.001 greater than or equal to 10% weight loss 41.5% 20.2% <0.001 55.2% 30.2% <0.001 greater than or equal to 15% weight loss 29.1% 10.9% <0.001 39.5% 17.9% <0.001 * ITT, last observation carried forward (LOCF) analysis included all randomized subjects with baseline and at least one post-baseline measurement while on study drug. ** p-value based on difference between Contrave and placebo.

In order to assess how early study drug discontinuations affect efficacy measures, a post-hoc sensitivity analysis was conducted. In this analysis, we included all randomized patients who received at least one dose of study drug and had at least one post-baseline measurement of body weight. Contrave patients lost an average of 17.6 pounds, or 8.1% of their baseline body weight, versus 10.6 pounds, or 4.9% of baseline body weight for placebo patients. This analysis also showed that 56.8% of Contrave patients lost at least 5% of their body weight compared to 42.9% for placebo patients. All of these results remained highly statistically significant.

Secondary endpoints that demonstrated clinically and statistically significant improvements over placebo included HDL, triglycerides, waist circumference and hsCRP, markers of cardiovascular risk. Contrave patients also demonstrated improvements in quality of life compared to placebo patients as measured by the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) scale, and decreases in sel
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SOURCE Orexigen Therapeutics, Inc.
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