Co-primary goals were achieved, and efficacy target was exceeded.
Orexigen Therapeutics reports that three late-stage evaluations of its obesity treatment, Contrave, met their co-primary endpoints. The firm plans on filing an NDA in the first half of 2010. Orexigen’s value shot up 23% to open the day at $7.
The results from the completed Contrave Obesity Research program of more than 4,500 patients exceed the FDA categorical efficacy benchmark for clinically significant weight loss, according to the company. In two studies, 48.0% and 56.3% of patients on Contrave lost at least 5% of their body weight after 56 weeks, approximately three times the placebo categorical response rates. Contrave patients showed a mean weight loss of 6.1% and 6.4% after 56 weeks, compared to 1.3% and 1.2% on placebo.
Contrave is a combination of antidpepressant bupropion (brand name, wellbutrin) and naltrexone. Additional analyses indicate that Contrave patients experienced reductions in the frequency and strength of food cravings and an increased ability to control their eating compared to placebo. “These results highlight the benefits of Contrave, a novel combination that was specifically designed to address the behavior and reward pathways in the brain that impact one’s ability to initiate and sustain weight loss,” remarks Mike Narachi, president and CEO of Orexigen.