Friday, January 24, 2014

Contrave: Perhaps the Next Obesity Drug to Be Approved by the FDA

Generally speaking, three approaches to weight loss and weight management are widely used. The three approaches are lifestyle modification, including diet and exercise, bariatric or weight loss surgery, and obesity drugs. While each approach can be successful, each approach has associated problems. It's hard to make lifetime lifestyle changes that include diet and exercise, bariatric surgery is often viewed as traumatic, and obesity drugs often give disappointing results.

Still, a successful obesity drug could represent the best weight loss tool for both obesity medicine providers and their patients. Already, two new obesity drugs have been approved. The two drugs are Qsymia, produced by Vivus, and Belviq, produced by Arena. However, neither one of the two drugs has had the impact within the weight loss industry that was desired or expected.

A third drug, which could be at least as successful as Qsymia and Belviq, is Contrave. Contrave is being produced by Orexigen Therapeutics.  The drug is a combination of the two FDA approved drugs, Bupropion and Naltrexone. Bupropion was approved by the FDA in 2006 for the treatment of depression. Naltrexone was approved in 1984, originally as a treatment for opiod addiction. However, the drug is commonly used in treating alcohol addiction.

Because it had some questions about Contrave's safety, the FDA was at first reluctant to approve the drug. However, because Contrave recently satisfied FDA criteria related to the drug's safety, Orexigen re- submitted a New Drug Application for the product to the FDA.  Some believe that the drug could be approved this year.

While obesity drugs, so far, have not done as well as desired, “the obesity drug market is expected to be in the billions of dollars.” And Orexigen’s obesity drug, Contrave, might be approved without a DEA controlled substance designation, unlike Qsymia and Belviq. And that could give Contrave an advantage, because the drug would be easier to purchase through retailers. This would benefit obesity medicine specialists and their patients.


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