BioCentury
ARTICLE | Company News

FDA to again review Orexigen's Contrave

January 8, 2014 1:30 AM UTC

Orexigen Therapeutics Inc. (NASDAQ:OREX) said FDA accepted for review a resubmitted NDA for Contrave naltrexone/bupropion for the management of obesity, including weight loss and maintenance of weight loss. The PDUFA date is June 10. The resubmission is based on an interim analysis in the Phase III Light Study, which showed that Contrave met FDA's pre-specified criteria for ruling out excess cardiovascular risk. The Light Study is evaluating CV outcomes with Contrave, which FDA requested in a 2011 complete response letter. In October, Orexigen submitted an MAA to EMA for the obesity candidate, which is partnered in North America with Takeda Pharmaceutical Co. Ltd. (Tokyo:4502). ...