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FDA approves Contrave; requires CV outcomes trial

September 11, 2014 2:32 AM UTC

FDA approved Contrave naltrexone/bupropion from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) 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.

Takeda and partner Orexigen Therapeutics Inc. (NASDAQ:OREX) had been hoping to use data from the ongoing Phase III Light Study to fulfill the CV outcomes requirement. Orexigen said details on the separate CV trial will be provided on an investor call on Thursday. ...