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The approval, which was was supported by data from a 56-week trial involving 223 obese individuals 12-17 years old, recommended the capsules be used in conjunction with a reduced-calorie diet and increased physical activity.
The US Food and Drug Administration (FDA) approved a supplemental indication for phentermine and topiramate extended-release capsules (Qsymia) for chronic weight management in pediatric patients 12 years and older who defined as having a body mass index (BMI) of 95th percentile or greater when standardized for age and sex.
The approval, which was was supported by data from a 56-week trial involving 223 obese individuals 12-17 years old, recommended capsules be used in conjunction with a reduced-calorie diet and increased physical activity.
A total of 54 patients were randomly assigned to the Qsymia 7.5 mg group, while 15 were enrolled in the 15 mg group and 56 in the placebo group.
All participants were counselled in lifestyle modification, which included reducing calories and increasing physical activity.
Overall, participants in the 7.5 mg and 15 mg treatment groups lost an overage of 4.8% and 7.1% of their BMI, respectively. Meanwhile, those who were on placebo gained an average of 3.3% of their BMI.
Back in 2012, the FDA approved phentermine and topiramate extended-release capsules for chronic weight management in adults with an initial BMI of 30 kg/m2 or greater or 27 kg/m2 or greater with 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.
The capsules are only available through a restricted program called the Qsymia Risk Evaluation and Mitigation Strategy (REMS), due to the increased risk for birth defects with fetal exposure to Qsymia during pregnancy,
Phentermine and topiramate extended-release capsules are also associated with increased heart rate, suicidal behavior and ideation, depression, the slowing of linear growth, acute myopia, secondary angle closure glaucoma, mood and sleep disorders, cognitive impairment, metabolic acidosis, and decrease in renal function.
The most common adverse reactions reported in the pediatric clinical trial included depression, dizziness, joint pain, fever, flu, and ankle sprain.