Friday, November 18, 2011

Weight Loss Drug One Step Closer To FDA Approval

Yet another experimental weight loss drug is making its way toward approval from the U.S. Food and Drug Administration (FDA). Researchers at the Univerity of Alabama's Nutrition Obesity Research Center published online in Obesity last week the results of a 56-week randomized, controlled trial to evaluate the safety and efficacy of a controlled-release combination of phentermine and topiramate, known as Qnexa. In addition to average weight loss of 14.4 percent of initial body weight among those who completed the study at the top dose of the combination, severely obese patients had improvements in blood pressure, glucose, triglycerides, and cholesterol. The results with Qnexa suggest the potential to effectively treat severely obese patients without surgery.

Vivus, Inc., the developer of Qnexa, also announced last week that the FDA has accepted for filing and review the New Drug Application for Qnexa for the treatment of obesity. The FDA is expected to make a decision on the application next April. 

Approval of Qnexa would make it the only prescription appetite suppressant available in the United States. Previous drugs in this class have been approved, but later withdrawn after reports of serious side effects. Read more in Psychiatric News.

(Image: bendao/


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