FDA approves weight management drug

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The U.S. Food and Drug Administration has approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as a treatment for chronic weight management.

The drug is approved for use in adults with a body mass index of 30 or greater or adults with a BMI of 27 or greater who have at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol. Contrave is a combination of two FDA-approved drugs, naltrexone and bupropion, in an extended-release formulation.

In a clinical trial, 42% of patients without diabetes treated with Contrave lost at least 5% of their body weight, compared with 17% of patients treated with placebo. Results from another clinical trial that enrolled patients with type 2 diabetes showed that patients had an average weight loss of 2% over treatment with placebo at one year. More than a third of these patients treated with Contrave lost at least 5% of their body weight.

“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 can cause seizures and must not be used in patients who have seizure disorders, experts note.