Orexigen’s Contrave Gets PDUFA Date

Orexigen Therapeutics has reported that the FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 10, 2014 for the companys recent resubmission of the Contrave (naltrexone sustained release (SR)/bupropion SR) NDA. The move indicates that the agency considers the NDA to be a complete response to the FDA’s January 31, 2011 action letter. Orexigen resubmitted the Contrave NDA in December 2013 following the  announcement of the successful interim analysis of Contrave’s cardiovascular outcomes trial, also known as the Light Study.

The Light Study is a double-blind, placebo-controlled trial that randomized approximately 8,900 patients. The primary objective of the Light Study, which Orexigen is conducting under a Special Protocol Assessment with the FDA at approximately 260 clinical sites in the U.S., is to rule out excess CV risk in overweight and obese patients receiving Contrave. In November 2013 Orexigen announced successful results of the interim analysis of the Light Study, stating that it met the prespecified criteria to exclude a hazard ratio of 2.0, using the upper bound of the 95% confidence interval, for excess risk of major adverse cardiovascular events (MACE) in patients receiving Contrave as compared to placebo.

Orexigen has licensed North American Contrave rights to Takeda Pharmaceuticals. Orexigen owns Contrave rights in Europe and throughout the rest of the world outside of North America and will seek a partner to commercialize Contrave in those territories. In October 2013, Orexigen submitted a Marketing Authorization Application (MAA) for Contrave to the European Medicines Agency (EMA).