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FDA Approves New Weight-Loss Pill

Update Date: Sep 11, 2014 09:29 AM EDT
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A third weight loss pill has entered the market after earning approval from the U.S. Food and Drug Administration (FDA). The drug, Orexigen Therapeutics's Contrave, was approved to help obese or overweight individuals with chronic weight management. These patients must have at least one health condition, such as hypertension or type 2 diabetes and should be exercising and dieting healthily as well.

"Obesity continues to be a major public health concern," Jean-Marc Guettier, director of the Division of Metabolism and Endocrinology Products in FDA's Center for Drug Evaluation and Research, said in a statement reported by Businessweek. "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."

Contrave was initially rejected by the agency in 2011 even though a panel of physicians had recommended the FDA to approve the treatment. After its rejection, the company temporarily suspended drug production. However, the company started a new trial and in this trial, the researchers found that Contrave was not associated with increasing a patient's risk of heart attack or other adverse events.

"Some individuals seeking to manage their weight may require a treatment plan that includes more than lifestyle modification with diet and exercise," added Dr. Ken Fujioka, director, Center for Weight Management, Division of Diabetes and Endocrinology at Scripps Clinic, according to MarketWatch. "Clinical trial data for Contrave demonstrates that this new treatment, when used as an adjunct to a reduced-calorie diet and increased physical activity, is a therapeutic option for some adults who are either overweight with a comorbidity, or obese. In my clinic, I often treat patients who fit these criteria, and now, with the approval of Contrave, I am excited to have a new treatment option to consider for my patients."

The other two weight loss drugs that earned FDA approval in 2010 are Vivus Inc.'s Qsymia and Belviq, marketed by Arena Pharmaceuticals Inc. and Eisai Co. There is currently no information on when the drug will become available and how much it would cost.

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