Experimental diet pill Qnexa to be reviewed by the FDA, again
Drug company Vivus is racing to be the first company to release a prescription diet pill onto the market in over a decade. The FDA will review their experimental weight loss pill Qnexa for a second time on Wednesday.
Qnexa, an experimental diet pill by drug maker Vivus, will be reviewed for a second time by the Food and Drug Administration next week, the Associated Press reported.
FDA officials have continued to voice their concerns about the safety of the drug, which was initially rejected in October 2010. Vivus is making second attempt to convince experts of the drugs’ safety on Wednesday, and have resubmitted the drug with additional follow-up information, hoping for a more favorable decision, USA Today reported.
Vivus, based in Mountain View, California, is one of three drug companies racing to put the first prescription weight loss drug on the market in over ten years, according to the AP. In the past two years, the FDA has rejected pills from Arena Pharmaceuticals, Orexigen Therapeutics, and Vivus. All three companies are in the process of resubmitting their products.
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Qnexa is a combination of appetite suppressant phentermine and anti-seizure drug topiramate, and was initially rejected because of its negative side effects, which include elevated heart rate and the potential for birth defects in pregnant women who used the drug, Reuters reported.
Several experts have predicted that Qnexa is the most likely to succeed on the market out of all three new diet pills because of the high level of weight loss reported in company studies, USA Today reported. On average, patients lost more than 10 percent of their total body mass while taking the pill.
However, experts voted 10-6 to not recommend the drug's approval at its' first FDA panel in 2010.
Another panel of FDA doctors will review the pill on Wednesday, when they will take a final vote on whether the drug is safe and effective or not, according to the AP. The group’s recommendation is not binding, and the FDA is expected to make a final ruling on Qnexa in April.
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US obesity rates are nearing 35 percent among adults, according to the New York Times, and doctors and public health officials have said that there is a desperate need for new weight-loss therapies.
Some obesity specialists have outlined a strong need for new obesity drugs to help with diet and exercise, which don’t work for many patients, and the more radical option of surgery, according to the Times. If approved, Qnexa could be used by millions of people.