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With SPA Finalized, Orexigen To Begin CV Outcomes Study For Contrave In Second Quarter

The company expects to be able to re-file the NDA for its obesity candidate by 2014, after 87 major adverse events were recorded in the 10,000-patient, placebo-controlled safety trial.

Having finalized a Special Protocol Assessment (SPA) with FDA that charts the course for a 10,000-patient cardiovascular safety outcomes trial, Orexigen Therapeutics Inc. says it can see a path forward to eventual approval of Contrave to combat obesity. Orexigen is competing with Vivus Inc. and Arena Pharmaceuticals Inc. to bring the first new obesity drug to market in over a decade.

San Diego-based Orexigen filed an NDA for Contrave (naltrexone/bupropion) in 2010 but received an FDA “complete response” letter in January 2011 citing a need for more data on cardiovascular safety, despite an FDA advisory committee having voted one month earlier 13-7 in favor of the drug’s approval Also see "

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