FDA Approves Orexigen's Long-Awaited Weight Loss Drug Contrave

Published: Sep 12, 2014

FDA Approves Orexigen Therapeutics, Inc.'s Long-Awaited Weight Loss Drug Contrave

September 11, 2014

By Krystle Vermes, BioSpace.com Breaking News Staff

The U.S. Food and Drug Administration has approved weight loss dug Contrave, Orexigen Therapeutics, Inc. announced late Wednesday.

Contrave, also known as naltrexone hydrochloride and bupropion hydrochloride, is used to help individuals with weight management and obesity.

The FDA has approved it for use in adults with a body mass index (BMI) of 30 (obese) or greater or 27 (overweight) or greater. Candidates must also have at least one weight-related condition such as high blood pressure or type 2 diabetes.

“Obesity continues to be a major public health concern,” said Jean-Marc Guettier, 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.”

A person's BMI measures body fat as a comparative metric to an individual’s weight and height. Contrave is a combination of two drugs, naltrexone and bupropion, and it is specifically designed for extended release.

The drug was evaluated for effectiveness in multiple clinical trials. About 4,500 obese and overweight patients were treated with Contrave for one year. They all altered their lifestyles with calorie-reduced meals and physical activity. After the data was compiled, researchers found that participants without diabetes had an average weight loss of 4.1 percent, compared to those who received a placebo.

Naltrexone is used to treat alcohol and opioid dependence, while bupropion is a common therapy for depression and seasonal affective disorder. It can also be used as an aid to smoking cessation treatments.

Medical professionals are advised to be mindful of side effects such as suicidal thoughts or tendencies in patients because Contrave includes bupropion. Doctors should also evaluate the state of patients 12 weeks after receiving the medicine to determine if it is effectively helping with weight loss. Ideally, a patient should lose at least 5 percent of his or her baseline body weight in order for Contrave to be deemed “successful.”

Some of the most common side effects associated with Contrave include nausea, constipation, vomiting and dizziness. Contrave can also raise blood pressure and heart rate in patients.

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