Viloxazine ER (Qelbree®) Administered with Psychostimulants in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: Topline Results of a Phase IV Safety Trial

This work was sponsored by Supernus Pharmaceuticals, Inc. Introduction: Approximately 10%-30% of individuals with ADHD experience inadequate response or have difficulty tolerating stimulant medications. Viloxazine extended-release (ER) is a nonstimulant, FDA-approved for pediatric (≥6 years) and adult ADHD. We report results of a phase IV, open-label safety study evaluating viloxazine ER administered with psychostimulants in pediatric (6-17 years) ADHD; morning vs. evening administration of viloxazine ER was also evaluated. Methods: Following screening period of ≤ 4 weeks, subjects who continued to experience inadequate efficacy (ADHD-RS-5 ≥24; CGI-S ≥3) to psychostimulant treatment (methylphenidate or amphetamine) received viloxazine ER, flexibly dosed (100-600 mg) each morning during Weeks 1-4 and evening during Weeks 5-8. Safety (primary outcome) and efficacy were evaluated relative to Baseline and for AM vs. PM viloxazine ER dosing. Results: Fifty-six subjects received viloxazine ER; 85.7% of these completed. Commonly reported adverse events (AEs) were headache (17.9%), decreased appetite (12.5%), and upper respiratory tract infection (10.7%); AEs led to discontinuation for 3.6%. Respective mean (SD) ADHD-RS-5 and CGI-S scores were Baseline (n=56): 37.2 (8.35) and 4.4 (0.56), Week 4 (n=54): 24.0 (11.66) and 3.6 (0.92) and Week 8 (n=48): 19.4 (12.08) and 3.1 (1.08), representing significant improvements from Baseline of -13.5 (9.7) and - 0.9 (0.92), and -18.2 (9.99) and -1.4 (1.10), respectively [All P<.0001 results="" were="" also="" significantly="" different="" for="" am="" vs.="" pm="" dosing="" conclusions:="" viloxazine="" er="" showed="" acceptable="" safety="" and="" tolerability="" when="" administered="" with="" stimulant="" medications.="" adhd="" symptoms="" improved="" following="" addition="" to="" stimulants="" both="" appearing="" safe="" effective.="">