SILVER SPRING, Md. — The Food and Drug Administration approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as a chronic weight-management option. The drug is approved for use in adults with a body mass index 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 high blood-pressure, Type 2 diabetes or high cholesterol.
BMI measures body fat in relation to an individual's weight and height and is used to define the obesity and overweight categories. More than one-third of adults in the United States are obese, according to the Centers for Disease Control and Prevention.
“Obesity continues to be a major public health concern,” said Jean-Marc Guettier, M.D., director of the division of metabolism and endocrinology products in FDA’s Center for Drug Evaluation and Research. “When used as directed in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, Contrave provides another treatment option for chronic weight management for people who are obese or are overweight and have at least one weight-related health condition.”
Contrave contains a combination of two drugs, naltrexone and bupropion. Naltrexone is indicated to treat alcohol and opioid dependence; bupropion is approved to treat depression and seasonal affective disorder and as an aid to smoking cessation treatment, the agency said. Both drugs are FDA-approved.
Contrave is distributed by Takeda Pharmaceuticals.