USA: The U.S. Food and Drug Administration (FDA) has approved Supernus' viloxazine (Qelbree) for the treatment of attention-deficit hyperactivity disorder (ADHD) in children aged 6 to 17 years.
The approval of Qelbree is based on data from an extensive development program consisting of four Phase III clinical trials that studied more than 1000 pediatric patients from the age of 6 to 17 years. In December 2020, the Company announced positive results from a Phase III trial in adult patients with ADHD and plans to submit a supplemental New Drug Application to the FDA for Qelbree in adults in the second half of 2021.
The results showed that children given viloxazine, a selective norepinephrine reuptake inhibitor, had greater improvement on an ADHD symptom severity scale, compared with those given placebo.
"Based on the efficacy demonstrated in the clinical program, we believe Qelbree offers a unique new alternative for the treatment of ADHD," said Jack A. Khattar, President and Chief Executive Officer 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 care givers who participated in and supported our research."
"ADHD is one of the most common mental health issues in the U.S.," said Andrew J. Cutler, M.D., 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."
Children taking the drug should be monitored for suicidal thoughts and behaviors, especially after treatment initiation and dosing changes. Suicidality rates were higher in clinical trials among those taking viloxazine.
The drug shouldn't be given concomitantly or within 14 days of stopping a monoamine oxidase inhibitor because of elevated risk for hypertensive crisis.