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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

- Improved Pharmacokinetic Characteristics of Naltrexone SR Associated with

Better Tolerability in Clinical Trials -

PHOENIX, Oct. 6 /PRNewswire-FirstCall/ -- Orexigen Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity and other central nervous system-related disorders, today presented data showing the investigational drug, Contrave(R) (naltrexone SR / bupropion SR), successfully achieved key objectives (lowered naltrexone Cmax, increased Tmax, comparable AUC) in two Phase 1 clinical trials. In addition, preliminary analysis of blinded data from nearly 4,000 patients participating in a series of four ongoing Phase 3 trials supports that the naltrexone SR formulation improvements are associated with tolerability advantages. Results from this series of investigations have been selected for presentation at The Obesity Society Annual Scientific Meeting.

"Contrave contains a sustained release formulation of naltrexone which we believe will improve tolerability, enhance patient compliance and improve weight loss outcomes in patients with obesity, a disorder which afflicts more than 75 million Americans," said Gary Tollefson, M.D., Ph.D., Orexigen President and CEO. "The Phase 3 formulation of naltrexone in an oral sustained release form may be a key factor in allowing more patients to achieve the potential benefits associated with greater weight loss."

About the Clinical Trials

The primary objective of the naltrexone sustained release (SR) development program was to improve tolerability by slowing the rate at which naltrexone dissolves, slowing its entry into the bloodstream (Tmax) and reducing the peak concentration it achieves in the blood (Cmax). A se
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SOURCE Orexigen Therapeutics, Inc.
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