Neuropsychiatric Disease and Treatment (Jun 2021)

The Effect of Viloxazine Extended-Release Capsules on Functional Impairments Associated with Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents in Four Phase 3 Placebo-Controlled Trials

  • Nasser A,
  • Hull JT,
  • Liranso T,
  • Busse GD,
  • Melyan Z,
  • Childress AC,
  • Lopez FA,
  • Rubin J

Journal volume & issue
Vol. Volume 17
pp. 1751 – 1762

Abstract

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Azmi Nasser,1 Joseph T Hull,1 Tesfaye Liranso,2 Gregory D Busse,3 Zare Melyan,3 Ann C Childress,4 Frank A Lopez,5 Jonathan Rubin6 1Department of Clinical Research, Supernus Pharmaceuticals, Inc., Rockville, MD, USA; 2Department of Biostatistics, Supernus Pharmaceuticals, Inc., Rockville, MD, USA; 3Department of Medical Affairs, Supernus Pharmaceuticals, Inc., Rockville, MD, USA; 4Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, NV, USA; 5Children’s Developmental Center, Winter Park, FL, USA; 6Supernus Pharmaceuticals, Inc., Rockville, MD, USACorrespondence: Azmi NasserDepartment of Clinical Research, Supernus Pharmaceuticals, Inc., 9715 Key West Ave, Rockville, MD, 20850, USAEmail [email protected]: The ADHD Rating Scale (ADHD-RS) assesses 18 symptoms of inattention and hyperactivity/impulsivity and has been used in many clinical trials to evaluate the treatment effect of drugs on ADHD. The fifth edition of this scale (ADHD-RS-5) also assesses the impact of inattention and hyperactivity/impulsivity symptoms on six domains of functional impairment (FI): family relationships, peer relationships, completing/returning homework, academic performance at school, controlling behavior at school, and self-esteem. Here, we report the effect of viloxazine extended-release capsules (viloxazine ER), a novel nonstimulant treatment for ADHD in children and adolescents (ages 6– 17 years), on FI from a post hoc analysis of four randomized, double-blind, placebo-controlled Phase 3 clinical trials (N=1354).Patients and Methods: ADHD-RS-5 investigator ratings of ADHD symptoms and FIs were conducted at baseline and weekly post-baseline for 6– 8 weeks in the four trials. Change from baseline (CFB) in ADHD-RS-5 FI scores (Total score [sum of 12 FI items] and Inattention and Hyperactivity/Impulsivity subscale scores [sum of 6 corresponding FI items]) and the 30% and 50% Responder Rates (ADHD-RS-5 FI Total score) were compared between viloxazine ER and placebo.Results: The reduction (improvement) in ADHD-RS-5 FI scores (Total and subscale scores) and the percentage of responders (30% and 50%) at Week 6 were significantly greater in each viloxazine ER dose group vs placebo. In the 100– 400 mg/day viloxazine ER groups, improvements were found as early as Week 1 (100-mg/day) or Week 2 (200-, 400-mg/day) of treatment. Analysis of individual items of ADHD-related FIs demonstrated that the effect of viloxazine ER was observed across all domains of impairment.Conclusion: Significant improvements observed in ADHD-related FIs are consistent with the reduction in inattention and hyperactivity/impulsivity symptoms demonstrated in the viloxazine ER Phase 3 pediatric trials. Therefore, viloxazine ER provides clinically meaningful improvement of ADHD symptoms and functioning in children and adolescents with ADHD, starting as early as Week 1– 2 of treatment.Keywords: impairment domains, academic performance, behavior, self-esteem

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