FDA approves phentermine/topiramate for pediatric chronic weight management
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The FDA approved a supplemental indication for phentermine/topiramate extended-release capsules for chronic weight management in pediatric patients aged 12 years and older with obesity, according to a press release.
The new indication is for phentermine/topiramate extended-release capsules (Qsymia, Vivus) to be used as additional therapy to a reduced-calorie diet and increased physical activity in pediatric patients aged 12 years and older with obesity, which was defined as a BMI of 95th percentile or greater when standardized for age and sex, according to the FDA release.
Phentermine/topiramate was approved by the FDA in July 2012 as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with a BMI of 30 kg/m2 or higher, or those with a BMI of 27 kg/m2 or higher and the presence of at least one weight-related comorbidity, such as hypertension, type 2 diabetes or dyslipidemia.
The new supplemental indication was based on a 56-week, double-blind, placebo-controlled trial of 223 individuals aged 12 to less than 17 years with a BMI at the 95th percentile or greater who were unable to lose weight or maintain weight loss with changes in diet and exercise. Individuals were randomly assigned to once-daily phentermine/topiramate 7.5 mg/46 mg, phentermine/topiramate 15 mg/92 mg or placebo. At the study end, participants in the 15 mg/92 mg group had a 7.1% reduction in BMI and those in the 7.5 mg/46 mg group had a 4.8% reduction, while those assigned placebo had an average 3.3% increase in BMI, according to the release.
The most common adverse reactions in the pediatric clinical trial included depression, dizziness, joint pain, fever, flu and ankle sprains. The effects of phentermine/topiramate extended-release on heart disease have not been established, and the drug has not been proven to treat weight loss in combination with other agents, according to the FDA.
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