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The US Food and Drug Administration (FDA) has approved the combination of bupropion/naltrexone, developed by Orexigen Therapeutics, to be known as Contrave, for the treatment of obesity.
Contrave’s maker had hoped for approval three years ago, but the FDA first demanded a safety study.
It’s approved for use in obese adults and clinically overweight adults who suffer from high blood pressure, type 2 diabetes, or high cholesterol.
According to the Centers for Disease Control and Prevention, more than one-third of adults in the United States are obese.
“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. “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 drug should not be used in patients who have eating disorders (bulimia or anorexia nervosa). Contrave should also not be taken by patients who are using opioids or treatments for opioid dependence, or who are experiencing acute opiate withdrawal. Patients undergoing an abrupt discontinuation of alcohol, benzodiazepines, barbiturates and antiepileptic drugs should not take Contrave. Women who are pregnant or trying to become pregnant should not take Contrave.
The most common adverse reactions reported with Contrave include nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea.
Agencies/Canadajournal
