Vivus Inc has presented on the additional benefits of Qnexa at the American College of Cardiology suggesting that the pharmaceutical company might be closer than ever to gaining FDA (Food and Drug Administration) approval for its weight loss drug. The drug helped patients decrease their blood pressure and levels of cholesterol after 2 years of treatment.
Patient dependence on blood pressure lowering treatment decreased on average by 19% and blood triglycerides decreased by 26%. Furthermore, there were no new safety risks reported in the study comprising 675 participants.
As we have previously posted, the FDA sent Qnexa away last October due to concerns that the drug could potentially be linked with heart risk and birth defects. The FDA decided that before approving the drug they would have to see benefits other than pure weight loss and this most recent study appears to give the FDA what it wants.
Vivus said in January that information on the history of oral cleft in children whose mothers took topiramate (one of the ingredients of Qnexa) would need to be reviewed. In January they estimated that this research would take 6 months to complete and so it looks like Vivus is the closest to gaining approval among the competing pharmaceutical companies. Arena is reviewing data on cancer risk and its drug Lorcaserin and will present results to the FDA by the end of the year. Orexigen has been sent away to review the potential heart risks associated with its drug, Contrave but this information could take years to gather.
Previous studies reveal that patients lost 10% of their original body weight with Qnexa, proving its potential and putting it out ahead of Lorcaserin and Contrave, which both assisted patients in losing just over 5% body weight over a year.