The U.S. Food and Drug Administration has approved a supplemental indication for Qsymia (phentermine and topiramate extended-release capsules) for chronic weight management in pediatric patients aged 12 years and older who are obese, defined as a body mass index (BMI) of 95th percentile or greater when standardized for age and sex. Qsymia should be used as additional therapy to reduced-calorie diet and increased physical activity.
FDA approved Qsymia 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 one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia, as an adjunct to a reduced-calorie diet and increased physical activity.
Disease or Condition
Adolescent obesity has increased over the last 50 years with 21% (1 in 5) of U.S. adolescents now considered obese. Obesity in pediatric patients is a serious condition and may adversely impact health by increasing the risk of many diseases, such as heart disease. Many obese children are likely to become obese adults. Lifestyle modification is recommended as first-line therapy; however, when lifestyle intervention is unsuccessful in reaching weight loss goals, medication may be considered.
The safety and effectiveness of Qsymia was evaluated in a 56-week, double-blind, placebo-controlled study of 223 individuals aged 12 to less than 17 years old with a BMI at the 95th percentile or greater for their age and sex, who had not been able to lose weight or maintain weight loss with changes to their eating habits or exercise routine. Eligible participants were randomly assigned to receive Qsymia 7.5 mg/46 mg (n=54), Qsymia 15 mg/92 mg (n=113), or placebo (n=56) once a day after a titration period to their assigned dose. All participants were counselled in lifestyle modification such as reducing calories and increasing physical activity.
At the end of the study, participants taking Qsymia 7.5 mg/46 mg and Qsymia 15 mg/92 mg lost, on average, 4.8% and 7.1% of their BMI, respectively, while individuals receiving the placebo gained an average of 3.3% of their BMI.
The effect of Qsymia on heart disease or death related to heart disease have not been established. The drug has not been proven to treat weight loss in combination with other products (such as prescription drugs, over-the-counter drugs, and herbal preparations).
Qsymia can cause fetal harm if taken while pregnant, including an increased risk of oral clefts (cleft lip and cleft palate). It is recommended that patients who can become pregnant obtain a negative pregnancy test result before starting Qsymia treatment, perform monthly pregnancy testing, and use effective contraception while taking Qsymia.
Because of the increased risk for birth defects (cleft lip and cleft palate) with fetal exposure to Qsymia during pregnancy, Qsymia is only available through a restricted program called the Qsymia Risk Evaluation and Mitigation Strategy (REMS).
Further information on the Qsymia REMS is available at www.qsymiarems.com or at 1-888-998-4887.
Qsymia comes with additional warnings and precautions: Qsymia is associated with increased heart rate; Qsymia is associated with suicidal behavior and ideation, patients should monitor for mood changes, depression or suicidal thoughts and discontinue Qsymia if symptoms develop; Qsymia is associated with slowing of linear growth, growth should be monitored in adolescents taking Qsymia. Additionally, Qsymia is associated with acute myopia, secondary angle closure glaucoma, and visual problems; 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. The most common adverse reactions in adults are a pins-and-needles sensation, dizziness, an altered or impaired sense of taste, insomnia, constipation, and dry mouth.
See the prescribing information for additional information on risks associated with Qsymia.
Qsymia received standard review for this indication.
FDA granted this supplement approval to Vivus, LLC.