Viloxazine ER Added to Stimulant Treatment for Pediatric ADHD Appears Safe, Effective

Extended-release viloxazine administered with stimulant medication improved symptoms of attention-deficit/hyperactivity disorder (ADHD) in pediatric patients with an initial inadequate response to stimulant medication, according to a poster presentation at Psych Congress. 

“Approximately 10% to 30% of individuals with ADHD experience inadequate response or have difficulty tolerating stimulant medications. Viloxazine extended-release (ER) is a nonstimulant, US Food and Drug Administration-approved [medication] for pediatric (≥6 years) and adult ADHD,” wrote first author Ann Childress, MD, of the Center for Psychiatry and Behavioral Medicine, Las Vegas, Nevada, and coauthors. 

The phase IV, open-label study included 56 patients with ADHD aged 6 to 17 years with an inadequate response methylphenidate or amphetamine. Patients received flexibly dosed viloxazine ER (100-600 mg) each morning during weeks 1 through 4 and each evening during weeks 5 through 8. The study’s primary outcome was safety, but efficacy was also evaluated relative to baseline and for morning compared with evening dosing of viloxazine ER.

According to the abstract, commonly reported adverse events were headache (17.9%), decreased appetite (12.5%), and upper respiratory tract infection (10.7%). Some 3.6% of participants discontinued viloxazine ER because of adverse events.

Mean improvements in ADHD Rating Scale-5 scores were 13.5 points at week 4 and 18.2 points at week 8, according to the study. Mean improvements in Clinical Global Impression-Severity scores were 0.9 points at week 4 and 1.4 points at week 8. 

“Viloxazine ER showed acceptable safety and tolerability when administered with stimulant medications,” the authors reported. “ADHD symptoms improved following viloxazine ER addition to stimulants, with both AM and PM dosing appearing safe and effective.”

Supernus Pharmaceuticals Inc. submitted the abstract.

Reference

Childress A, et al. Viloxazine ER (Qelbree) administered with psychostimulants in children and adolescents with attention-deficit/hyperactivity disorder: topline results of a phase IV safety trial. Poster presented at Psych Congress; September 6-10, 2023; Nashville, Tennessee.