An experimental weight-loss drug may be one step closer to FDA approval. Researchers at the University of Alabama’s Nutrition Obesity Research Center published online November 3 in Obesity the results of a 56-week randomized, controlled trial to evaluate the safety and efficacy of Qnexa, a controlled-release combination of phentermine and topiramate. 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 researchers said their results with Qnexa suggest the potential to treat severely obese patients effectively without surgery.
Vivus, the developer of Qnexa, also announced last week that the FDA has accepted the New Drug Application for Qnexa as an obesity treatment. A decision on the application is expected in April 2012.