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Recently, the FDA announced the approval of supplemental indication for phentermine and topiramate extended-release capsules for chronic weight management in children aged 12 years and older.
Recently, the US Food and Drug Administration (FDA) announced it has approved a supplemental indication for phentermine and topiramate extended-release capsules (Qsymia; Vivus LLC) for chronic weight management in pediatric patients aged 12 years and older considered obese. Obese is defined as a body mass index (BMI) of 95th percentile or greater when standardized for age and sex. The drug should be as supplemental therapy in addition to a reduced-calorie diet and increased physical activity.
Currently, 21% of US adolescents (1 in 5) are considered obese, a percentage that has increased over the last 50 years. As pediatric obesity is a serious condition that may adversely impact health, the FDA recommends lifestyle medication as first-line therapy, or if lifestyle intervention is not effective, medication may be considered.
The FDA originally approved phentermine and topiramate extended-release capsules in July 2012 for chronic weight management in adults with an “initial BMI of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least 1 weight-related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia, as an adjunct to a reduced-calorie diet and increased physical activity,” according to the press release announcing the approval.
The safety and efficacy of phentermine and topiramate extended-release capsules was evaluated in a 56-week, double-blind, placebo-controlled study of adolescents aged 12 to less than 17 years old. The study participants—223 in total—included had a BMI at the 95th percentile or greater for their age and sex and were unable to lose weight or maintain weight loss with changes in eating or exercise.
Randomized participants were assigned to receive the drug at doses 7.5 mg/46 mg (n = 54), 15 mg/ 92 mg (n = 113), or placebo (n = 56) once a day after a titration period to their assigned dose. Additionally, they were all counselled in lifestyle changes including eating habits and increased exercise.
Study results showed that those taking the drug at doses 7.5 mg/46 mg and 15 mg/ 92 mg lost an average of 4.8% and 7.1% of their BMI, respectively. In comparison, participants receiving placebo gained an average of 3.3% of their BMI.
FDA approves treatment for chronic weight management in pediatric patients aged 12 years and older. US Food and Drug Administration. Published June 27, 2022. Accessed June 28 2022. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-chronic-weight-management-pediatric-patients-aged-12-years-and-older/?utm_medium=email&utm_source=govdelivery