Contrave refiled with FDA for Obesity-Orexigen Therapeutics

Orexigen Therapeutics has resubmitted the Contrave (naltrexone sustained release (SR)/bupropion SR) New Drug Application to the FDA 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.

In January 2011, Orexigen received a Complete Response Letter (CRL) from the FDA detailing a single approval deficiency�the need to conduct a clinical trial of sufficient size and duration to exclude excess risk of major adverse cardiovascular events. Since then Orexigen has negotiated with FDA a feasible CVOT design, enrolled the CVOT, and generated safety data responsive to the CRL. The review period for the resubmission is expected to be six months.