The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) 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 12 years of age and older with body mass index (BMI) in the 95th percentile or greater standardized for age and sex. 

The approval was based on data from a randomized, double-blind, placebo-controlled, parallel-design phase 4 study (ClinicalTrials.gov Identifier: NCT03922945) that evaluated the efficacy and safety of Qsymia in 223 patients 12 to 17 years of age with a BMI at the 95th percentile or greater standardized for age and sex. Patients were randomly assigned 1:2:1 to receive Qsymia 7.5mg/46mg, Qsymia 15mg/92mg, or placebo once daily for 56 weeks after a titration period. All patients were offered a family-based lifestyle modification program.

Findings showed that at the end of the study, treatment with Qsymia resulted in statistically significant reduction in BMI (primary endpoint) compared with placebo (-4.8% with 7.5mg/46mg dose and -7.1% with 15mg/92mg dose vs +3.3% with placebo). Moreover, a greater proportion 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 established. The safety and efficacy of Qsymia in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have also not been established.

The rate of weight loss should be monitored in pediatric patients. A dosage reduction should be considered in pediatric patients if weight loss exceeds 0.9kg/week.

Qsymia, a Schedule IV controlled substance, 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/m2or greater (obese), or 27kg/m2 or greater (overweight) in the presence of at least 1 weight-related comorbidity, such as hypertension, type 2 diabetes mellitus, or dyslipidemia.

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

References

  1. FDA approves treatment for chronic weight management in pediatric patients aged 12 years and older. News release. US Food and Drug Administration. Accessed June 27, 2022. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-chronic-weight-management-pediatric-patients-aged-12-years-and-older
  2. Qsymia. Package insert. Vivus, Inc.; 2022. Accessed June 27, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022580s021lbl.pdf