FDA Approves Second Diet Drug In A Month

By Scott Hensley

Published July 18, 2012 at 8:59 AM CDT

The range of Qsymia doses approved by the Food and Drug Administration Tuesday.

After a 13-year hiatus, the Food and Drug Administration gave its OK to the second weight-loss drug in a month.

This time it's Qsymia, previously called Qnexa, from Vivus. The pill contains two active ingredients: topiramate, an anti-seizure medicine, and phentermine, a stimulant.

The two medicines, both generic now, have been around for years. By combining relatively low doses in a single pill, Qsymia helps suppress appetite and gives people a feeling of fullness more quickly after eating.

Qsymia, (say CUE-sim-ee-ah) is approved for treating obese adults (a body mass index over 30) or those who are overweight and have one weight-related condition, such as diabetes, high blood pressure or high cholesterol.

In studies leading up to approval, patients lost an average of about 8 percent of their original body weight in a year. Earlier research suggests a 5 percent weight loss can provide a benefit health.

The once-a-day pill (taken in the morning to minimize insomnia) has side effects, including mood disturbances, fuzzy thinking and an increase in heart rate. People with glaucoma shouldn't take the drug.

The topiramate in Qsymia can cause birth defects, and the drug isn't for use by women who are pregnant. Women of child-bearing age who take the drug will have to use effective contraception.

Because of the drug's risk during pregnancy, Qsymia will only be available from approved mail-order pharmacies.

Peter Tam, president of Vivus, told USA Today that the drug will be available to by the fourth quarter. A price wasn't released, but Tam told the paper it will not be "outrageous." Insurance companies probably won't cover the cost of the drug at first.

The FDA's approval of Qsymia was expected, and the biggest excitement Tuesday came when USA Today published an online story prematurely. After taking the story down, the paper posted this explanation, according to the blog Retraction Watch:

USA TODAY inadvertently published a story online this morning saying the Food and Drug Administration had given approval to the diet drug Qsymia (kyoo sim ee' uh). The story was prepared in anticipation of FDA approval, but at this hour that approval is still pending.