Orexigen announced that its three Phase 3 trials evaluating Contrave (bupropion SR/naltrexone SR) for the treatment of obesity have met their co-primary and key secondary endpoints. The results from the completed Contrave Obesity Research (COR) program of more than 4,500 patients exceed the FDA categorical efficacy benchmark for clinically significant weight loss, supporting Orexigen’s plan to file a New Drug Application (NDA) with the FDA in the first half of 2010. All Phase 3 trials in the COR program were 56-week, randomized, double-blind, placebo-controlled trials. The co-primary endpoints showed a significantly greater proportion of patients treated with Contrave to have achieved at least 5% weight loss and percent change in body weight compared to placebo. Secondary endpoints met across the COR program included significant improvements in multiple measures of cardiovascular and metabolic risk factors (eg, waist circumference, visceral fat, HDL cholesterol and triglycerides), food cravings and eating control, as well as HbA1c in the COR Diabetes trial.
Contrave is an investigational drug combining an aminoketone with an opioid antagonist for the treatment of obesity by working within the central nervous system to control the balance of food intake and metabolism, as well as food preference, reward, and cravings.
For more information call (858) 875-8600 or visit www.orexigen.com.