13 May 2015 | News | By BioSpectrum Bureau
Takeda, Orexigen terminate Cardiovascular Outcomes Study
Singapore: Takeda and its wholly-owned subsidiary, Takeda Development Center Americas Incorporation and Nasdaq-listed Orexigen Therapeutics Incorporation have decided to enforce an early termination of the Light Study, a cardiovascular (CV) outcomes trial.
Both the companies 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 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 8,909 overweight and obese patients with certain CV risk factors.
At the time of the United States approval of Contrave in September 2014, the US Food and Drug Administration (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 CV 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.