Supernus receives FDA OK for Qelbree

Supernus Pharmaceuticals has obtained the Food and Drug Administration’s nod for Qelbree (SPN-812) (viloxazine extended-release capsules) for the treatment of attention-deficit hyperactivity disorder in pediatric patients 6 to 17 years of age.

“Based on the efficacy demonstrated in the clinical program, we believe Qelbree offers a unique new alternative for the treatment of ADHD,” said Jack Khattar, president and CEO of Supernus Pharmaceuticals. “Qelbree provides prescribing physicians and patients living with ADHD a therapy that is not a controlled substance with proven efficacy and a tolerable safety profile. We are grateful to the patients, families and their caregivers who participated in and supported our research.”

“ADHD is one of the most common mental health issues in the U.S.,” said Andrew Cutler, clinical associate professor of psychiatry at SUNY Upstate Medical University, and chief medical officer, Neuroscience Education Institute. “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.”