FDA Approves Weight-Loss Drug Qsymia
On July 17, the FDA approved Qsymia (phentermine and topiramate extended-release) as an addition to a reduced-calorie diet and exercise for chronic weight management. The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obese) or in adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition, such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).
BMI, which measures body fat based on an individual’s weight and height, is used to define obesity and overweight categories. According to the Centers for Disease Control and Prevention, more than one-third of adults in the U.S. are obese.
Qsymia is a combination of two FDA-approved drugs, phentermine and topiramate, in an extended-release formulation. Phentermine is indicated for short-term weight loss in overweight or obese adults who are exercising and eating a reduced-calorie diet. Topiramate is indicated to treat certain types of seizures in people who have epilepsy and to prevent migraine headaches.
The recommended daily dose of Qsymia contains 7.5 mg of phentermine and 46 mg of topiramate extended-release. Qsymia is also available at a higher dose (15 mg of phentermine and 92 mg of topiramate extended-release) for select patients.
In two clinical trials, 1 year of treatment with the recommended and highest daily dose of Qsymia provided an average weight loss of 6.7% and 8.9%, respectively, compared with placebo. Approximately 62% and 69% of patients lost at least 5% of their body weight with the recommended dose and highest dose of Qsymia, respectively, compared with about 20% of the placebo group.
Qsymia should not be used during pregnancy or in patients with glaucoma or hyperthyroidism. Qsymia can increase the heart rate; the drug’s effect on heart rate in patients at high risk for heart attack or stroke is not known. The most common side effects of Qsymia are tingling of the hands and feet (paresthesia), dizziness, altered taste sensation, insomnia, constipation, and dry mouth.
Qsymia is marketed by Vivus Inc. in Mountain View, Calif.
For more information, visit the FDA Web site.