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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Sunday, January 5, 2014

Two Potential Weight Loss Drugs: Victoza and Beloranib

The FDA has approved several obesity drugs over the past sixty years. Some of the drugs were approved for short term use, and some were approved for use long term. Some of these drugs were found to have serious side effects, and taken off the market. Two new drugs, Belviq and Qsymia, were approved by the FDA in 2012. And a third drug, Contrave, produced by Orexigen Therapeutics, is expected to be approved within a year or so. However, two drugs, Victoza and Beloranib, are also receiving attention as potential weapons in the weight loss battle.

Denmark based Novo Nordisk is the maker of Victoza (liraglutide), an analog of GLP-1. Novo Nordisk has been investigating the drug as a weight loss treatment. Liraglutide is already approved by the FDA as a type 2 diabetes treatment, gaining the approval in 2010.

Novo Nordisk feels that the FDA’s approval of Qsymia and Belviq presents an opportunity for other weight loss drugs. And because of positive phase lll trial results "that demonstrate liraglutide can reduce a person's weight by 8 per cent over a 56-week period," Novo Nordisk is expected to begin filling for approval in the EU and the U.S. in 2014.

Massachusetts based Zafgen has "released phase 2 data ... showing that its obesity drug Beloranib was capable of helping patients lose 24 pounds or about 10.8% of their body weight after just 12 weeks on the highest dose of the drug."

So Zafgen's drug results are more impressive than those of Vivus' drug Qsymia or Orexigen's drug Belviq. Qsymia and Belviq usage resulted in a weight loss of 5.8% to 9.8% over a period of a year. (Contrave and Victoza usage produced similar results.)

While Victoza and Beloranib are receiving attention as weight loss drugs, there is one thing that may limit their use: They are both injected, while the other approved weight loss drugs are taken orally. Still, Victoza and Beloranib could be important additions to the weight loss arsenal. And obesity medicine specialists might want to these drugs' progress.

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