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FDA Agrees to Review Weight-Loss Drug Contrave (Naltrexone/Bupropion)
Approval decision expected in June 2014 (January 7)
The FDA has considered the recent resubmission of a New Drug Application (NDA) for Contrave (naltrexone sustained release [SR]/bupropion SR, Orexigen Therapeutics/Takeda) to be a complete response to the agency’s January 31, 2011, action letter.
For the resubmission, the FDA has assigned a Prescription Drug User Fee Act goal date of June 10, 2014. If approved, Contrave is expected to be launched in the second half of 2014.
The NDA for Contrave was resubmitted in December 2013 following an interim analysis of the ongoing Light study — a double-blind, placebo-controlled cardiovascular outcomes trial involving approximately 8,900 patients. This study met prespecified criteria to exclude a hazard ratio of 2.0 for an excess risk of major adverse cardiovascular events in patients treated with Contrave compared with placebo.
Before the start of the Light study, Contrave was evaluated in clinical trials that enrolled more than 4,500 subjects. In these studies, 53% of participants taking Contrave and 21% of those taking placebo lost 5% or more of their body weight over 12 months of treatment.
Source: Orexigen Therapeutics; January 7, 2013.