On June 27, 2022, the FDA approved the supplemental New Drug Application for Qsymia (phentermine and topiramate extended-release capsules) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in pediatric patients aged 12 years and older with a BMI in the 95th percentile or greater standardized for age and gender.

Initially approved in July 2012 by the FDA for adults, Qsymia is a schedule IV controlled substance, which is also indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial BMI of 30kg/m2 or greater (obese), or 27kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).

Approval was based on data from a randomized, double-blind, placebo-controlled, parallel-design phase IV study that evaluated the efficacy and safety of Qsymia in 223 patients aged 12 to 17 years with a BMI at the 95th percentile or greater standardized for age and gender. Patients were randomly assigned 1:2:1 to receive Qsymia 7.5 mg/46 mg, Qsymia 15 mg/92 mg, or placebo once daily for 56 weeks after a titration period. All patients were offered a family-based lifestyle modification program.

The findings demonstrated that at the end of the study, treatment with Qsymia resulted in statistically significant decrease in BMI (primary endpoint) compared with placebo (-4.8% with 7.5 mg/46 mg dose and -7.1% with 15 mg/92 mg dose vs. +3.3% with placebo). Moreover, a greater percentage of patients treated with Qsymia achieved 5%, 10%, and 15% reductions in BMI (secondary endpoints) compared with placebo.

The most common adverse reactions reported in pediatric patients were depression, dizziness, arthralgia, pyrexia, influenza, and ligament sprain. In the pediatric trial, a reduction in height velocity was observed in patients treated with Qsymia.

The effect of Qsymia on cardiovascular morbidity and mortality has not been determined. The safety and efficacy of Qsymia in combination with other products intended for weight loss, including prescription drugs, OTC drugs, and herbal preparations, has not been established.

The rate of weight loss should be monitored in pediatric patients, and clinicians should consider a dosage reduction in pediatric patients if weight loss exceeds 0.9 kg/week.

Qsymia is only available through a restricted program called the Qsymia Risk Evaluation and Mitigation Strategy.

The product is supplied as an extended-release capsule containing phentermine/topiramate in the following strengths: 3.75 mg/23 mg, 7.5 mg/46 mg, 11.25 mg/69 mg, and 15 mg/92 mg.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

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