Qnexa, the most promising pill for weight-loss in over a decade, has been given a thumbs-down by the FDA. Vivus Inc., the maker of the drug, stated that the Food and Drug Administration has asked more study results and additional information regarding potential health issues related to Qnexa. Such major health concerns include cardiovascular events and risks for women with childbearing potential. At this point the FDA has not issued demands for new studies concerning the drug, but it's possible that more may be required if concerns remain unaddressed.
With the overwhelming demand for so called "miracle pills" to aide in weight loss, Vivus and two other small companies were in the running for creating an approved drug. Vivus maintained the top spot with test results boasting of more than 10% loss in total body mass on average, while currently marketed drugs only maintain a loss of about 5%. That all changed in July when Qnexa took a hard hit from the FDA who voted against the drug's approval 10-6. Reasons for the panel's decision were speculations that the drug was responsible for a number of side effects such as heart palpitations, birth defects, suicidal thoughts, and lapses in memory. According to doctors, the need for weight-loss drugs is high, especially with obsesity and diabetes rates rising on a global scale. They also acknowledge that this drug class is not without a history of safety issues.
The FDA's ruling against Qnexa could possibly have an adverse effect on the industry as a whole. Dr. Tim Garvey of the University of Alabama states, "If there isn't any kind of path forward for this drug, I think it is going to shut down all obesity drug devleopment for a decade." Garvey has conducted two of the trials for Qnexa as well as consulting for Vivus. The company is still holding onto hope for approval of Qnexa, stating that they would submit more details at the FDA's request.
Qnexa is the second drug for weight-loss to be rejected by the FDA in the past week.