Qnexa won an overwhelming endorsement from public health advisers, raising hopes that the drug from Vivus Inc. could become the first new anti-obesity medication to reach the U.S. market in more than a decade. The panel’s 20-2 vote amounts to a recommendation that the FDA approve the drug for sale.

Qnexa was invented by Dr. Thomas Najarian in 2003. When FDA rejected Qnexa in 2010, the agency asked Vivus for two-year clinical data.

Clinical studies showed Qnexa led to an increased heart rate in some patients but it also reduced blood pressure, making the long-term effects on the heart unclear.

Qnexa actually combines low doses of two ingredients: the stimulant phentermine, used for weight loss, and topiramate, the active ingredient in Johnson & Johnson’s Topamax, a drug used for migraine that can cause birth defects, suicidal ideation, and problems thinking. Together, they are among the more effective weight loss pills in clinical trials.

Other studies of the topiramate in Qnexa have suggested an increased birth-defect risk. Vivus has proposed a program to educate women of childbearing age about the risk of Qnexa and the need to use birth control while taking it.

Some doctors are already using the combination of the drugs to treat obesity, which is why some FDA panel members said it was important to get Qnexa on the market so that patients have appropriate benefit and risk information.

Qnexa would be targeted at adults who are considered obese or who are overweight and have another weight-related condition like high blood pressure, type 2 diabetes, or high cholesterol. Patients have lost about 10% of their bodyweight on average from the drug.The pill would be given once daily.

The FDA is holding a meeting in late March on how obesity medicines should be tested for heart risk.

Tags: FDA, health, Lose Weight, obesity, obesity medicines, Qnexa, Weight Loss Pill