On September 10, 2014, The U.S. Food and Drug Administration (US FDA) approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) for anti-obesity treatments in combination with a reduced-calorie diet and exercise. Contrave is distributed by Takeda Pharmaceuticals America Inc. of Deerfield, Illinois for Orexigen Therapeutics, Inc. of La Jolla, California.
The FDA approved the naltrexone hydrochloride and bupropion hydrochloride drug combo for use by people with a body mass index of 30 or higher. 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 high blood pressure (hypertension), diabetes, or high cholesterol (dyslipidemia).
The naltrexone and bupropion drug combo are already approved for alcohol and narcotic dependence. In addition, naltrexone has already been approved for treating alcohol and narcotic dependence, and bupropion has already been approved as an antidepressant to help people quit smoking.
In addition to Contrave, the FDA has approved 2 other drugs for anti-obesity treatments, including 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.
In experiments, non-diabetic patients lost 4.1 percent more weight than patients who took a fake pill.
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 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.
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 in the fall of 2014.
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