FDA Approves New Weight Loss Drug

By Larry Husten

Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS

The FDA has approved Contrave, a combination of two drugs already approved for other indications. Naltrexone hydrochloride is used to combat alcohol and opioid dependence, and bupropion is prescribed for depression, seasonal affective disorder, and smoking cessation.

Contrave is approved for use in obese adults or in overweight adults with at least one weight-related condition like hypertension, type 2 diabetes, or dyslipidemia.

In one clinical trial, significant weight loss — at least 5% of body weight — was achieved by 42% of people who received Contrave and 17% of those who received placebo.

The FDA said that people starting Contrave should be evaluated after 12 weeks. Patients who've failed to lose at least 5% of their body weight should discontinue the drug.

Because Contrave contains bupropion, the label will include a boxed warning pointing to the increased risk for suicidality.