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Orexigen(R) Therapeutics Presents Data on Its Proprietary Formulation of Naltrexone Sustained Release (SR) Used in Contrave(R)
Date:10/6/2008

dverse event (13.8% versus 16.0%).

-- Across the Contrave Phase 3 trial experience to date, only 7.6% of all reported adverse events led to an early discontinuation from the trials.

In summary, naltrexone SR met its primary objectives by providing a lower peak plasma concentration (Cmax) than the legacy IR formulation while retaining a similar total plasma exposure (AUC). This held true both for the parent molecule (naltrexone) and its principal active metabolite (6-beta-naltrexol). In a Phase I pilot study, improved tolerability was suggested amongst those who received naltrexone SR / bupropion SR than those receiving the prior Phase 2 formulation containing naltrexone IR. Finally, in a blinded, pooled analysis of preliminary Phase 3 data, results suggest that naltrexone SR / bupropion SR may be associated with decreased rates of treatment-emergent nausea, headache, dizziness, or discontinuation due to an adverse event.

About Orexigen(R) Therapeutics

Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity and other central nervous system-related disorders. The Company's lead combination product candidates targeted for obesity are Contrave(R), which is in Phase 3 clinical trials, and Empatic(TM), which is in the later stages of Phase 2 clinical development. Each product candidate is designed to act on a specific group of neurons in the central nervous system with the goal of achieving appetite suppression and sustained weight loss. Beyond obesity, Orexigen is developing drug combinations for use in schizophrenia and obsessive-compulsive disorder. Further information about the company can be found at http://www.Orexigen.com.

About Contrave(R)

Contrave is an investigational weight loss medication with a mechanism of action that works at two sites within the central nervous system. The first is a hypothalamic site that controls the balanc
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SOURCE Orexigen Therapeutics, Inc.
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