U.S. regulators are greenlighting a new weight-loss drug called Contrave, the third in a string of approvals for anti-obesity treatments.
The drug was developed by Orexigen Therapeutics Inc., based in La Jolla, California. The Food and Drug Administration said Thursday that it is approved for use by people who have a body mass index of 30 or higher, which is the level at which people are considered to be obese. It is also approved for use by people with a BMI of 27 or higher who also have a weight-related medical condition such as diabetes.
"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, in a press statement. "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."
The agency approved the drug for use in combination with a reduced-calorie diet and exercise.
Contrave is a combination of two drugs that are already approved, naltrexone and bupropion. Naltrexone is used to treat alcohol and narcotic dependence. Bupropion is an antidepressant also used to help people quit smoking.
In testing, patients without diabetes who used the drug lost 4.1 percent more weight than those who took a placebo.
The drug will have a boxed warning about the risk of suicidal thoughts associated with antidepressants like Bupropion. Additional risks include the possibility of seizures, as well as increased blood pressure and heart rates. The FDA recommends physicians who prescribe the drug evaluate their patients after 12 weeks to determine if it is working. If a patient has not lost at least 5 percent of their body fat, the drug should be discontinued.
The heart effects created a long road to approval for Contrave. The FDA refused to approve the drug in 2011, citing cardiovascular risks. Orexigen resubmitted its application to regulators in December, saying that the drug fared well in an early analysis of a study designed to rule out excessive cardiovascular risk.
In addition to Contrave, the FDA has approved Qsymia from Vivus Inc. and Belviq from Arena Pharmaceuticals Inc. Sales of the drugs, once considered potential billion-dollar sellers, have been below expectations because of limited insurance coverage and high costs for patients.
Contrave will be distributed in the U.S. by Japanese drugmaker Takeda Pharmaceuticals, which will pay Orexigen royalties on sales. Orexigen and Takeda plan to start selling the drug this fall.