FDA Expands Approval of Vivus’ Qsymia for Chronic Weight Management in Obese Teenagers

The FDA has expanded its approval of Vivus’ oral drug, Qsymia (phentermine and topiramate extended-release capsules), to include obese adolescents who are 12 years and older.

The drug was first approved in 2012 as an adjunct treatment for chronic weight management in obese adults with a weight-related comorbidity. The drug is indicated for use with a reduced-calorie diet and increased physical activity.

The expanded approval was based on a 223-participant study in which the group who received the treatment saw a greater reduction in their body mass index compared with those taking placebo.

The FDA is requiring a risk evaluation and mitigation strategy (REMS) for Qsymia because of the risk of birth defects from fetal exposure during pregnancy.