VIVUS LLC announced that the U.S. Food and Drug Administration (FDA) approved QSYMIA (phentermine and topiramate extended-release capsules) CIV for use in the treatment of obesity in adolescents (12-17 years old) with an initial body-mass index (BMI) in the 95th percentile or greater standardized for age and sex. According to the CDC, approximately 22% of children aged 12-19 years in the United States — about 14 million individuals — have obesity. The results of the QSYMIA Phase 3 trial in adolescent patients taking the top-dose demonstrated that more than 44% of patients lost at least 15% of their body weight and more than 30% of patients lost at least 20% of their body weight.

Adolescence is a critical period for the development of obesity. Obesity arises from a complex interaction among numerous factors, including a strong biological component. The increased prevalence of adolescent obesity in the United States and its associated short- and long-term complications underscore the need for safe and effective treatment.

Chronic obesity-related health conditions such as type 2 diabetes, insulin resistance, hypertension, dyslipidemia, obstructive sleep apnea and fatty liver disease, were previously only seen in adults but are now being diagnosed with increasing frequency in adolescents. Obesity also diminishes adolescents' quality of life, and excess adiposity often carries into adulthood.