An FDA advisory panel has given its nod to the weight loss drug Qnexa.
Manufactured by VIVUS, Inc., Qnexa is a combination of the appetite suppressant phentermine and the anti-seizure/migraine drug topiramate. The drug was denied approval in 2010 due to concerns about potential heart problems and birth effects.
This time around, the advisory panel reviewed two years of data on the drug. In 2010, only one year of data was available. The Committee voted 20 to 2 for approval based on a favorable benefit-risk profile. The panel stated that patients on Qnexa should be monitored closely for potential heart problems. They also suggested possible warning label targeted toward women of childbearing age.
As far as weight loss goes, obese patients taking Qnexa lost an average 22 pounds over a year and saw reducticions in blood pressure and cholesterol levels.
The FDA is expected to decide whether or not to approve Qnexa by April 17, 2012. They are not obliged to follow the advice of their advisory panels, but they usually do.
Source: Vivus, Inc.
