Topiramate and Phentermine Still Potentially Dangerous

With the FDA reconsidering the diet pill Qnexa which is a combination Topiramate and Phentermine, there are still many unanswered questions that need to be addressed with this diet pill combination. The resubmission comes after Vivus the company that manufactures Qnexa and the FDA reached an agreement on filing strategy in September. The strategy being that these combinations of pills were very dangerous for women who are pregnant or could become pregnant.

However, Vivus may miss out on a large part of the market if it cannot sell to young women. More than 50% of the likely market could be comprised of women of childbearing age. More women than men are also believed to be willing to pop a diet pill. In the Phase III trials for Qnexa, 70-83% of the participants were women, a figure that’s typical for obesity treatments.

The two main ingredients in Qnexa topiramate and phentermine, have been on the market separately for many years, Vivus had hoped that the drugs’ record of safety would help guide Qnexa through the approval process, however, a new issue appeared. Qnexa patients showed an increase in heart rate, and the FDA expressed concerns that this lead could lead to cardiovascular issues.

Despite these setbacks, Qnexa has proven to help patients lose weight. In three clinical trials, Qnexa patients lost 30 lbs on average over a one year span, nearly 5 times what patients who took the placebo lost. It is clear that the FDA will focus on safety, rather than on efficacy in its reevaluation of Qnexa. In July 2010, an FDA panel met to discuss the approval prospects of Qnexa and voted against 10-6. One of the panel members, Abraham Thomas, stated that, “In terms of efficacy, it’s far superior to anything on the market.”

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