Viloxazine: Pediatric First Approval

Viloxazine (QELBREE((TM))), a selective norepinephrine reuptake inhibitor, is being developed by Supernus Pharmaceuticals as a non-stimulant for the treatment of attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients. This is a novel formulation of a pharmacological agent formerly marketed in Europe for the treatment of depression in adults. Viloxazine received its first pediatric approval in April 2021 in the USA for the treatment of ADHD in pediatric patients aged 6-17 years. Approval was based on positive results from a series of short-term phase III clinical trials in which viloxazine improved the severity of ADHD symptoms in children and adolescents with diagnosed ADHD. Viloxazine is available as extended-release capsules for once-daily oral administration. This article summarizes the milestones in the development of viloxazine leading to this first pediatric approval for ADHD.

Automated summary

Viloxazine, a selective norepinephrine reuptake inhibitor developed by Supernus Pharmaceuticals, has been approved for pediatric use in treating ADHD in the USA. Positive results from short-term phase III clinical trials supported its approval for improving ADHD symptoms in children and adolescents.