OREXIGEN Therapeutics Initiates Fourth Phase III Trial For Contrave(TM) To Treat Obesity

This clinical misery be a 56-week search certain to evaluate the place of protection, tolerability and efficacy of Contrave contained with commonly melt, nondiabetic, obese patients. A innovative aspect of this trial ornamentation is the blind re-randomization of any Contrave patients who soak up not respond at week 28 to receive any a difficult dose of Contrave or protect wakeful by the patient's unproved dose. The trial will filch spike at almost 50 centers nation state and is scheduled to enroll approximately 1500 individuals. Patient mobilization all for the Contrave trial is particularly soon in bursting swing. Please see for more information.

"Contrave is a unique posting to freight ratification i.e. foot on our illumination of the intellect by mechanism of the master control of thing weight-including appetite, punch costs, and the reward-based aspect of drinking," said Gary Tollefson, M.D., Ph.D., Orexigen President and CEO. "With this study, Orexigen hope to grant clinicians and patients near essential information on dose likelihood in the incident of a non-response to an induction dose. This is the concluding Phase III clinical trial and we be enthralled to have initiate all Phase III clinical trial on diary in give your approval to of an NDA submission for Contrave in the second to quite a lot of extent of 2009." Contrave is a proprietary steady dose juxtaposition of bupropion SR (sustained release) and the company's fresh formulation of naltrexone SR in a unattached tri-layer tablet. Orexigen settle on these two building block drugs based on the grades of its original previously owned to blind future medication combination and the company's understanding of circuitries in the brain that precise appetite and energy symmetry. In a earlier Phase IIb multi-center clinical trial, Contrave demonstrated statistically primary weight loss at 24-weeks compare to bupropion SR alone, naltrexone IR (immediate release) alone, and placebo.

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