Orexigen announced data from its COR-Diabetes trial for Contrave (naltrexone sustained release (SR)/bupropion SR) for weight lowering and improved glycemic control in obese patients with type 2 diabetes. COR-Diabetes was a 56-week placebo-controlled, double-blind randomized trial of 505 overweight or obese patients with type 2 diabetes, whose A1C levels were between 7% and 10% (mean=8.0%), with most patients already taking multiple oral diabetes medications. Patients were randomized to receive either Contrave32 (naltrexone 32mg SR /bupropion 360mg SR) or placebo in a 2:1 ratio. Over twice as many patients lost at least 5% of their body weight on Contrave versus placebo on an intent-to-treat (ITT) basis (44.5% vs. 18.9% respectively). Average baseline A1C, the standard test for monitoring glycemic control, of approximately 8.0% was reduced by 0.6% for Contrave compared to 0.1% for placebo. This translated to over 44% of Contrave patients reaching the American Diabetes Association (ADA) treatment target for A1C of less than 7%. In comparison, 26% of placebo patients reached the same threshold (p<0.001). Orexigen had previously announced the submission of Contrave’s New Drug Application (NDA) in April 2010.
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.