Interim Analysis of Efficacy During Long-Term Treatment with Viloxazine Extended-Release Capsules (Qelbree®) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder

Abstract: Viloxazine ER (Qelbree®) is a novel, nonstimulant, FDA-approved treatment for ADHD in pediatric patients (≥6 years) and adults. The efficacy of viloxazine ER was evaluated in 4 double-blind (DB), placebo-controlled, phase 3 trials in children and adolescents that fed into an ongoing open-label extension (OLE) safety trial. Change from DB baseline (CFB) in the ADHD Rating Scale, 5th Edition (ADHD-RS-5) Total score, ADHD-RS-5 Responder Rate (≥50% reduction in CFB total score), and Clinical Global Impression-Improvement (CGI-I) Responder Rate (CGI-I score 1 or 2) by visit and last OLE on-study visit were assessed. Overall, at data cut (31Dec2020), 961 pediatric Phase 3 patients had received viloxazine ER in the OLE trial; 562 (58.5%) patients had received viloxazine ER for ≥6 months and 387 (40.3%) patients for ≥12 months. At Week 6 of DB, the CFB ADHD-RS-5 Total score [LS Mean (SE)] was -17.1 (0.45) in the viloxazine ER (n=902) and -11.7 (0.64) in the placebo (n=452) group; the treatment difference was -5.4 (0.78), PShort Description: The efficacy of viloxazine ER was evaluated in 4 double-blind, placebo-controlled, phase 3 trials in children and adolescents with ADHD that fed into an ongoing open-label extension safety trial. Results suggest children and adolescents taking viloxazine ER can experience continued efficacy and potentially further improve ADHD symptoms with long-term use.Name of Sponsoring Organization(s): Supernus Pharmaceuticals Inc.