The approval marks the first novel non-stimulant treatment for ADHD.
The FDA has approved viloxazine extended-release capsules (Qelbree; Supernus Pharmaceuticals) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients ages 6 to 17 years.1
Viloxazine is a serotonin norepinephrine modulating agent. With this approval, viloxazine represents the first novel non-stimulant treatment for ADHD.1
The approval is based on data from 4 phase 3 clinical trials involving more than 1000 pediatric patients between the ages of 6 and 17. Each of the 4 pivotal studies demonstrated a reduction in ADHD-RS-5 total score as early as week 1 that continued until the end of the clinical study, as well improvement in both hyperactivity/impulsivity and inattention subscales. The effect was statistically significant across the 100-mg, 200-mg, and 400-mg doses. Viloxazine also had an acceptable safety profile with low incidence of adverse events (AEs) and low discontinuation rates.2
“ADHD is one of the most common mental health issues in the US,” said Andrew J. Cutler, MD, clinical associate professor of psychiatry at SUNY Upstate Medical University and chief medical officer, Neuroscience Education Institute.1 “The right treatment is key for children and adolescents as they grow and navigate school and social relationships. This approval offers a novel once a day sprinkleable non-stimulant that can be a great option for children and adolescents with ADHD.”
In December 2020, Supernus announced positive results from a phase 3 study of the treatment in adults with ADHD, and has plans to submit a supplemental New Drug Application (NDA) to the FDA for this indication in the second half of 2021.1