Executive Function Outcome of Treatment with Viloxazine Extended-Release Capsules in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: A Post-Hoc Analysis of Four Randomized Clinical Trials.

Abstract

AIM:

The aim of this study was to evaluate the effect of viloxazine extended-release capsules (viloxazine ER; Qelbree™) on executive function deficits (EFDs) in pediatric subjects (6-17 years of age) with attention-deficit/hyperactivity disorder (ADHD).

METHODS:

Data from four phase III placebo-controlled trials of 100-600 mg/day viloxazine ER (6-8 weeks of treatment) were used to evaluate the change from baseline (CFB) in the Conners 3rd Edition Parent Short Form-Executive Function (C3PS-EF) content scale T-score. Subjects were defined as EFD responders if they had C3PS-EF T-score > 70 at baseline and < 65 at end of study. ADHD symptoms were assessed with ADHD Rating Scale 5th Edition (ADHD-RS-5). Subjects were defined as ADHD symptom responders if they had a ≥ 50% reduction in CFB ADHD-RS-5 Total score at Week 6. The number needed to treat (NNT) and Cohen's d effect sizes were estimated for EFD and ADHD symptoms.

RESULTS:

A total of 1154 subjects were included in the analysis. Statistically significant improvements in EFDs were observed with viloxazine ER versus placebo (p = 0.0002). There were 52.5% of EFD or ADHD symptom responders in the viloxazine ER treatment group and 35.4% in the placebo group (p < 0.0001). The NNT was 5.8. The Cohen's d effect size for EFD and ADHD symptoms was 0.31.

CONCLUSION:

Consistent with the efficacy of viloxazine ER demonstrated in pivotal trials, viloxazine ER significantly reduced EFDs in subjects with ADHD. Moreover, a substantial proportion of subjects treated with viloxazine ER had large improvements in EFDs, ADHD symptoms, or both.

CLINICAL TRIAL REGISTRATION NUMBERS:

NCT03247530, NCT03247517, NCT03247543, NCT03247556.

• Authors: Stephen V Faraone, Roberto Gomeni, Joseph T Hull, Gregory D Busse, Zare Melyan, Jonathan Rubin, Azmi Nasser
• Journal: Paediatric drugs (Paediatr Drugs) Vol. 23 Issue 6 Pg. 583-589 (Nov 2021) ISSN: 1179-2019 [Electronic] Switzerland
• PMID: 34523063 (Publication Type: Journal Article)
• Copyright: © 2021. The Author(s).

Chemical References

• Central Nervous System Stimulants
• Delayed-Action Preparations
• Viloxazine

Topics

• Adolescent
• Attention Deficit Disorder with Hyperactivity (drug therapy)
• Central Nervous System Stimulants
• Child
• Delayed-Action Preparations
• Dose-Response Relationship, Drug
• Double-Blind Method
• Executive Function
• Humans
• Randomized Controlled Trials as Topic
• Treatment Outcome
• Viloxazine (therapeutic use)