The approval allows the tablets for use in chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight).
Both the companies agreed to several post-marketing requirements, including studies to assess the safety and efficacy of Contrave for weight management in obese pediatric patients, as part of the approval.
Takeda Pharmaceuticals USA president Douglas Cole said the FDA approval of Contrave is a significant milestone in the company’s and Orexigen’s commitment to leading innovation in medicine for patients and physicians dealing with chronic conditions and diseases, such as obesity.
"It’s important that physicians and appropriate patients have options when discussing weight management, especially when you look at the prevalence of obesity in today’s society," Cole said.
"We’re excited about the addition of Contrave to our Cardiovascular and Metabolic Disease Portfolio."
Contrave includes two components, naltrexone, an opioid antagonist, and bupropion, a relatively weak inhibitor of the neuronal reuptake of dopamine and norepinephrine.
The tablets are expected to be commercially launched in fall this year, and are recommended to be used along with a low-calorie diet and exercise regimen.
In order to evaluate the efficacy of Contrave, four 56-week multicenter, double-blind, placebo-controlled obesity trials have been conducted in 4,536 patients.
The trials showed the percent change from baseline in body weight and a decrease in body weight of around 5%.
Another clinical trial, LIGHT study is also being planned by the companies to assess the occurrence of major adverse cardiovascular events in overweight and obese adults with cardiovascular risk factors receiving Contrave.