Contrave naltrexone SR/bupropion SR regulatory update

FDA approved a resubmitted NDA from Orexigen for Contrave naltrexone/bupropion as an adjunct to diet and exercise for chronic weight management in adults with obesity or who are overweight with co-morbidities. The agency is requiring an additional postapproval cardiovascular outcomes trial with a pre-specified goal to exclude excess CV risk with a hazard ratio of 1.4. The approval triggered a $30 million milestone payment from commercialization partner Takeda Pharmaceutical Co. Ltd. (Tokyo:4502, Osaka, Japan). Orexigen expects Takeda to launch the drug in the U.S. this fall, which will trigger an additional $70 million milestone payment.

Orexigen said details on the design of the separate CV trial still need to be worked out. A final protocol is due by April 2015, with final data due by January 2022. The partners had hoped to use data from the ongoing Phase III Light Study to fulfill the CV outcomes requirement. The resubmitted NDA included an interim analysis of the Light Study showing that Contrave met FDA's pre-specified criteria for excluding excess CV risk with a hazard ratio of 2. ...