Qsymia is only available through a Risk Evaluation and Mitigation Strategy (REMS) program because of the increased risk for birth defects.
The FDA has approved a supplemental indication for Vivus’s Qsymia (phentermine and topiramate extended-release capsules) for chronic weight management in adolescents aged 12 years and older who are obese. Qsymia was originally approved in 2012 for adults who are obese.
The approval was based on data from a 56-week, placebo-controlled study of 223 people aged 12 to less than 17 years old with a body mass index (BMI) at the 95th percentile or greater. Patients taking Qsymia 7.5 mg/46 mg and Qsymia 15 mg/92 mg lost, on average, 4.8% and 7.1% of their BMI, respectively, while individuals receiving the placebo gained an average of 3.3% of their BMI.
Adolescent obesity has increased over the last 50 years with 21% (1 in 5) of U.S. adolescents now considered obese. Obesity in pediatric patients is a serious condition and may adversely impact health by increasing the risk of many diseases, such as heart disease. Many obese children are likely to become obese adults.
Because of the increased risk for birth defects (cleft lip and cleft palate) with fetal exposure to Qsymia during pregnancy, Qsymia is only available through a Risk Evaluation and Mitigation Strategy (REMS) program. Qsymia is only available through certified pharmacies.