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Orexigen and Takeda Announce Multiple Contrave Data Presentations at the ObesityWeek Meeting in Atlanta
Date:11/11/2013

temprop="name">Susan McElroy, MD; Research Institute, Lindner Center of HOPE, Mason, OH, USA.
Title: Naltrexone/bupropion is associated with early and longer-term improvement in binge eating disorder that is related to improvement in depression

About Contrave
About Contrave (32 mg naltrexone sustained‐release (SR)/360 mg bupropion SR) being evaluated for the treatment of obesity: In 2012, Orexigen enrolled more than 10,400 with approximately 8900 randomized patients in the Light Study. The primary objective of the double‐blind, randomized, placebo‐controlled Light Study, which Orexigen is conducting under a Special Protocol Assessment with the U.S. Food and Drug Administration (FDA), is to assess the occurrence of major adverse cardiovascular events in overweight and obese patients receiving Contrave. An interim analysis of the Light Study is anticipated by early December, enabling the potential resubmission of the Contrave New Drug Application to the FDA by year end.

In October, Orexigen submitted a Marketing Authorization Application for Contrave to the European Medicines Agency.

Orexigen has licensed North American Contrave commercial rights to Takeda Pharmaceuticals. Orexigen owns Contrave rights in Europe and throughout the rest of the world outside of North America and will seek a partner to commercialize Contrave in those territories.

About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. The company's lead product candidate is Contrave, which has completed Phase 3 clinical trials and for which a NDA has been submitted and reviewed by the FDA. The company has also reached agreement with the FDA on a SPA for the Light Study, the Contrave cardiovascular outcomes trial. The company's other product candidate, Empatic, has completed Phase 2 clinical t
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SOURCE Orexigen Therapeutics, Inc.; Takeda Pharmaceuticals, U.S.A., Inc.
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