- The FDA has approved Orexigen and Takeda's Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) for chronic weight management in conjunction with diet and exercise.
- Contrave is now approved for use in adults with a BMI of 30 or higher, or in adults with BMI of 27 and higher who also have conditions like hypertension, type 2 diabetes, or high cholesterol.
- The FDA demanded more safety data from Orexigen when the company originally applied for Contrave approval in 2011. The agency has approved two other weight loss medications in the last two years, Arena’s Belviq and Vivus’ Qsymia.
The clinical trial data supporting Contrave's approval is certainly compelling. According to the FDA, a study using patients without type 2 diabetes yielded at least 5% reduction in body weight among 42% of trial participants. Furthermore, a trial addressing diabetic patients saw 36% of enrollees lose at least 5% body weight -- double the figure of the placebo-treated group.
But if history is any indication, Contrave may not become a blockbuster overnight. First, there are concerns over the drug's side effects, including possible seizures and increased blood pressure and heart rates. Furthermore, Arena and Vivus' weight loss pills haven't exactly taken the market by storm.