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

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; 3D...

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Autores principales:	Nasser A, Hull JT, Liranso T, Busse GD, Melyan Z, Childress AC, Lopez FA, Rubin J
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	impairment domains academic performance behavior self-esteem Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/812d44ea523f45a3826568c89782970b
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spelling	oai:doaj.org-article:812d44ea523f45a3826568c89782970b2021-12-02T17:21:57ZThe 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 Trials1178-2021https://doaj.org/article/812d44ea523f45a3826568c89782970b2021-06-01T00:00:00Zhttps://www.dovepress.com/the-effect-of-viloxazine-extended-release-capsules-on-functional-impai-peer-reviewed-fulltext-article-NDThttps://doaj.org/toc/1178-2021Azmi 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 anasser@supernus.comPurpose: 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-esteemNasser AHull JTLiranso TBusse GDMelyan ZChildress ACLopez FARubin JDove Medical Pressarticleimpairment domainsacademic performancebehaviorself-esteemNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 17, Pp 1751-1762 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	impairment domains academic performance behavior self-esteem Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	impairment domains academic performance behavior self-esteem Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Nasser A Hull JT Liranso T Busse GD Melyan Z Childress AC Lopez FA Rubin J 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
description	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 anasser@supernus.comPurpose: 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
format	article
author	Nasser A Hull JT Liranso T Busse GD Melyan Z Childress AC Lopez FA Rubin J
author_facet	Nasser A Hull JT Liranso T Busse GD Melyan Z Childress AC Lopez FA Rubin J
author_sort	Nasser A
title	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
title_short	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
title_full	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
title_fullStr	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
title_full_unstemmed	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
title_sort	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
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/812d44ea523f45a3826568c89782970b
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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

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