Takeda and Orexigen announced the early termination of the Light Study, a cardiovascular (CV) outcomes trial following the recommendation of the Executive Steering Committee (ESC).
The Light Study compared Contrave (naltrexone HCl and bupropion HCl extended-release) tablets to placebo, in addition to diet and exercise counseling in overweight and obese patients with certain CV risk factors (n=8,909). The Study is not being stopped due to a finding of superiority or harm. Takeda, Orexigen, and the ESC plan on reporting the final study data in a scientific forum once all the of the CV events in the Light Study have been collected and processed.
The Food and Drug Administration (FDA) required a new CV outcomes trial as a post-marketing requirement for Contrave to evaluate the effects of long-term treatment on the incidence of major adverse CV events in overweight and obese subjects with CV disease or multiple CV risk factors. This new trial is anticipated to begin later in 2015 with a target completion date of 2022.
Contrave combines naltrexone HCl, an opioid antagonist, and bupropion HCl, an aminoketone. It is indicated as adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of ≥30kg/m2 or ≥27kg/m2 in the presence of at least one weight-related comorbidity (eg, hypertension, type 2 diabetes, or dyslipidemia).
For more information call (877) 825-3327 or visit Contrave.com.