Trials & Filings

Orexigen Resubmits Contrave NDA

CVOT data may support approval

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Orexigen Therapeutics has resubmitted its NDA for Contrave to the FDA. Contrave (naltrexone sustained release (SR) / bupropion SR) is an investigational drug udner development for weight loss and maintenance of weight loss. The resubmission follows the November 25, 2013 announcement of the successful interim analysis of the Light Study, the Contrave cardiovascular outcomes trial (CVOT), which is being conducted under a Special Protocol Assessment with the FDA. The study a double-blind, placebo-...

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