Sept. 10, 2014 — The U.S. Food and Drug Administration today approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.
The drug is approved for use in adults with a body mass index of 30 or greater (obesity) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia). Contrave is a combination of two FDA-approved drugs, naltrexone and bupropion, in an extended-release formulation.
Results from a clinical trial that enrolled patients without diabetes showed that patients had an average weight loss of 4.1 percent over treatment with placebo (inactive pill) at one year. In this trial, 42 % of patients treated with Contrave lost at least 5 % of their body weight compared with 17 % of patients treated with placebo.
Contrave is distributed by Takeda Pharmaceuticals America Inc. of Deerfield, Illinois for Orexigen Therapeutics, Inc. of La Jolla, California.
Marketdata Commentary
OK, you know the story by now. Get ready for the stock analyst forecasts for multi-billion dollar annual sales. Right. We’ve been there before. There are side effects with this drug, and MDs are still wary of using these drugs due to past issues with others. No magic pill here with only 5% weight loss.