Third weight-loss drug approved for obese adults

A third weight management drug, Contrave, has received FDA approval for use in obese and overweight adults.

Contrave, a combination pill of naltrexone hydrochloride and bupropion hydrochloride in an extended-release formulation, by Orexigen Therapeutics, now joins two other obesity drugs-Belviq (locarserin HCl) by Arena/Eisai and Qysmia (phentermine and topiramate extended- release capsules) by Vivus-as treatment options for obesity.

Related content: Investigational study of Contrave

Patients with a body mass index (BMI) of 30 or greater and those with a BMI of 27 or greater who have at least one of the following conditions-hypertension, type 2 diabetes, or dyslipidemia-can be prescribed Contrave to help lose excess pounds along with exercise and diet.

More than one third of U.S. adults are obese, according to the Centers for Disease Control and Prevention.

“The Obesity Society researchers and clinicians agree that losing weight solely by altering lifestyle changes, while effective for some people, can often be difficult to accomplish, and even more difficult to maintain. Additional treatment strategies, such as antiobesity medications like Contrave, are important tools in the clinician’s toolbox for treating obesity,” said Lee Kaplan, MD, PhD, fellow of The Obesity Society, and director of Obesity, Metabolish, and Nutrition Institute, Massachusetts General Hospital.

Contrave’s efficacy was demonstrated in clinical trials of approximately 4,500 obese and overweight patients who also had weight-related conditions and were treated for one year. Exercise and diet were also part of their treatment regimens. Three different clinical trials showed an average weight loss range of 2% to 5% in a higher percentage of patients who received Contrave than placebo.

Patients prescribed Contrave should be evaluated 12 weeks after starting therapy to determine if they have lost 5% of their baseline weight. The drug should be stopped if this goal of 5% weight loss has not been achieved, according to FDA.

Contrave has a boxed warning because it contains the antidepressant bupropion, which warns of suicidal ideation and behavior associated with antidepressants. In addition, it carries a warning of serious neuropsychiatric events that have occurred in individuals taking bupropion for smoking cessation. The drug also should not be used by patients with seizure disorders or with uncontrolled hypertension.

In the clinical trials, common side effects associated with Contrave were nausea/vomiting, constipation/diarrhea, headache, dizziness, insomnia, and dry mouth.

FDA is requiring post-marketing studies to evaluate the cardiovascular risk with Contrave’s use, pediatric use, and the dosing of Contrave in patients with hepatic and renal impairment. The agency also has requested a study to evaluate potential interactions of Contrave with other medications.