The U.S. Food and Drug Administration announced the approval Wednesday of the new weight-loss drug Contrave, a mix of antidepressant and alcohol dependence medications.
The drug, which is intended to be used along with a low-calorie diet and exercise regimen, is approved for use in obese adults (body mass index of 30 or greater) or overweight adults (BMI of 27 or greater) who also suffer a weight-related condition, such as high blood pressure or Type 2 diabetes, according to regulators.
The medication, which is manufactured by Orexigen Therapeutics Inc. of La Jolla, combines the drugs naltrexone, which is used to treat alcohol and opioid dependence, and the drug bupropion, which is prescribed for depression, seasonal affective disorder and smoking cessation.
Orexigen initially sought approval from the FDA in 2011 but was asked to conduct further testing on the drug’s cardiovascular risks.
About one-third of Americans are classified as obese, and Dr. Jean-Marc Guettier, director of the FDA’s division of metabolism and endocrinology products, said Contrave can help address this national problem.
Clinical trials designed to test Contrave’s effectiveness involved 4,500 obese and overweight patients who were treated for one year.
In one trial, 42% of patients who received the drug lost at least 5% of their body weight, and 17% of the patients who received a placebo experienced similar results.
In a trial that involved patients suffering from Type 2 diabetes, 36% of Contrave-treated patients lost at least 5% of their weight, compared with 18% of patients who received a placebo, the FDA said.
The drug comes with a number of cautions.
A boxed warning will alert healthcare providers to an increased risk of suicidal thoughts and behaviors associated with antidepressant drugs.
“Contrave can cause seizures and must not be used in patients who have seizure disorders,” read an FDA news release. “Contrave can also raise blood pressure and heart rate and must not be used in patients with uncontrolled high blood pressure.”
The drug should also not be used in patients who have eating disorders, such as bulimia or anorexia nervosa, the FDA said.
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