FDA Approves Takeda’s Weight Management Combination Drug
The US Food and Drug Administration has approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) from Takeda Pharmaceuticals and the biopharmaceutical company, Orexigen Therapeutics, as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.
The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obesity) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition, such as hypertension, Type 2 diabetes, or high cholesterol.
Contrave is a combination of two FDA-approved drugs, naltrexone and bupropion, in an extended-release formulation. Naltrexone is approved to treat alcohol and opioid dependence. Bupropion is approved to treat depression and seasonal affective disorder and as an aid to smoking cessation treatment.
Takeda plans to launch the product in the fall of 2014 in the United States. Takeda is commercializing the drug in North America, and Orexigen in the rest of the world. Orexigen has applied for marketing authorization for the drug in Europe and anticipates a decision on approval in 2014.
