Orexigen Therapeutics has submitted an NDA to the FDA for Contrave (naltrexone SR/bupropion SR), its investigational drug for the treatment of obesity. The NDA is based on a substantial body of evidence gathered through the Contrave Obesity Research (COR) clinical program, which included more than 4,500 patients.

“The COR program was designed to address all the elements of the FDA guidance for weight loss and weight maintenance in patients with obesity. We believe that if approved, Contrave has the potential to serve the diverse needs of obese patients who currently have few treatment options,” said Mike Narachi, president and chief executive officer of Orexigen.

According to Orexigen, 48% and 56% of patients on Contrave lost at least 5% of their body weight in the COR-I and COR-II trials on an intent-to-treat basis, as compared to 16% and 18% of placebo patients who lost at least 5%, respectively (p<0.001). In addition, significant improvements were observed in cardiometabolic risk factors such as waist circumference, visceral fat, C-reactive protein, HDL cholesterol and triglycerides.

The safety profile of Contrave was found to be consistent with the safety of the two approved active ingredients.