The Impact of Long-Term Treatment with Viloxazine Extended-Release Capsules (Qelbree®) on Executive Function in Adults with Attention-Deficit/Hyperactivity Disorder

Abstract: Viloxazine ER is a novel, nonstimulant, FDA-approved treatment for ADHD in children and adults (≥ 6 years). Viloxazine ER effects on executive function (EF) deficits were evaluated in adults with ADHD in a double-blind (DB), flexible-dose (200–600 mg/day), phase 3 trial (NCT04016779) and ongoing open-label extension (OLE) trial. EF was evaluated using the Behavior Rating Inventory of Executive Function–Adult Version (BRIEF-A), Global Executive Composite (GEC), Metacognition Index (MI), and Behavioral Regulation Index (BRI). The change from baseline (CFB) to week 6 (end of DB study), EF of subjects treated with viloxazine ER (n=175) significantly improved vs placebo (n=179) as depicted by BRIEF-A LS Mean (SE) T-Scores on the GEC: [-9.3 (0.87) vs. -6.8 (0.85), PShort Description: Viloxazine ER effects on executive function deficits were evaluated in adults with ADHD in a double-blind, flexible-dose (200–600 mg/day), phase 3 trial (NCT04016779) and ongoing open-label extension (OLE) trial. The results of the OLE indicate that adults with ADHD can achieve continued improvement in executive function during long-term treatment with viloxazine ERName of Sponsoring Organization(s): Supernus Pharmaceuticals Inc.