NDA for Weight Loss Drug Contrave Resubmitted

Orexigen announced that it has resubmitted a New Drug Application (NDA) to the FDA for Contrave (naltrexone sustained release [SR]/bupropion SR), an investigational drug for weight loss and maintenance of weight loss.

The resubmission was based on successful interim analysis of the Light Study, the Contrave cardiovascular outcomes trial (CVOT). The FDA had issued a Complete Response Letter in January 2011, stating that Orexigen needed to conduct a clinical trial of sufficient size and duration to exclude excess risk of major adverse cardiovascular events.

The Contrave Light Study is a double-blind, placebo-controlled cardiovascular outcomes trial that randomized approximately 8,900 patients. The primary objective of the Light Study was to rule out excess cardiovascular risk in overweight and obese patients receiving Contrave. The prespecified criteria to exclude a hazard ratio of 2.0 was met, using the upper bound of the 95% confidence interval, for excess risk of major adverse cardiovascular events (MACE) in patients receiving Contrave compared to placebo.

Contrave is an investigational drug combination of an aminoketone with an opioid antagonist for the treatment of obesity. It works within the central nervous system to control the balance of food intake and metabolism, as well as food preference, reward, and cravings.

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