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Contrave is a combination of two already-approved drugs, naltrexone and bupropion, in extended-release form. The former is approved to treat alcohol or opioid dependence, while the latter is approved for depression, seasonal affective disorder and as a smoking-cessation aid.
The drug is approved for use in people with a body-mass index (BMI) of 30 or higher, which is considered obese, the FDA said in a news release. It also is sanctioned for people with a BMI of 27 or higher, which is considered overweight, who also have at least one weight-related chronic health condition. Such a condition would include high blood pressure, high cholesterol or type 2 diabetes.
More than one-third of adults in the United States are obese, the FDA said, citing the U.S. Centers for Disease Control and Prevention.
Contrave was evaluated in clinical trials involving some 4,500 obese and overweight people. Results showed people who took Contrave had an average weight loss of 4.1 percent more than people given a placebo.
People who take Contrave should be evaluated after 12 weeks to determine if treatment has worked, the FDA advised. The drug's label will have a boxed warning of the possibility of suicidal thoughts and behaviors associated with antidepressants.
The FDA said it ordered a number of post-marketing studies, including an evaluation of any cardiovascular risks and of the drug's use among children.
Contrave is distributed by Takeda Pharmaceuticals, of Deerfield, Ill.
-- Scott Roberts
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