Takeda Pharmaceutical Company Ltd and its wholly-owned subsidiary, Takeda Development Center Americas, Inc. (Takeda) and Orexigen Therapeutics, Inc. have accepted the recommendation of the Executive Steering Committee (ESC), chaired by Dr Steven Nissen of The Cleveland Clinic, for early termination of the Light Study, a cardiovascular (CV) outcomes trial that compared the obesity drug Contrave (naltrexone HCI and bupropion HCl extended-release tablets) to placebo, in addition to diet and exercise counselling, in 8909 overweight and obese patients with certain CV risk factors. The Light Study is not being terminated due to a finding of superiority or harm. The ESC, Takeda and Orexigen expect to report the final Light Study data in a scientific forum after all of the CV events in the Light Study have been collected and properly adjudicated.
At the time of US approval of Contrave in September 2014, the FDA required a new CV outcomes trial as a post-marketing requirement (PMR) for the evaluation of the effects of long-term treatment with Contrave on the incidence of major adverse cardiovascular events (MACE) in overweight and obese subjects with CV disease or multiple CV risk factors. This new CV outcomes trial is expected to begin later this year and has a target completion date of 2022.
