Orexigen announced that a New Drug Application (NDA) has been submitted to the FDA seeking approval of Contrave (naltrexone SR/bupropion SR) for the treatment of obesity. This submission is based on Orexigen’s Contrave Obesity Research (COR) clinical program, which included four Phase 3 randomized, double-blind, placebo-controlled trials, with a four week titration period. The co-primary endpoints were the proportion of patients achieving at least 5% weight loss and percent change in body weight compared to placebo. Secondary endpoints included multiple measures of cardiometabolic risk, quality of life, and control of eating, as well as HbA1c in the COR-Diabetes trial.
Contrave is an investigational combination of an opioid antagonist and an aminoketone, believed to address both physiological and behavioral drivers of obesity. The central pathways targeted by this treatment are involved in controlling the balance of food intake and metabolism, and regulating reward-based eating behavior.
For more information call (858) 875-8600 or visit www.orexigen.com.