@article{3ad7429070ce4b9f86084e1c093d3744,
title = "A Phase II Double-Blind, Placebo-Controlled, Efficacy and Safety Study of SPN-812 (Extended-Release Viloxazine) in Children With ADHD",
abstract = "Objective: The objective of this study is to evaluate efficacy and safety of SPN-812 (extended-release viloxazine) for ADHD in children aged 6 to 12 years. Method: In an 8-week study, 222 participants were randomized to placebo or SPN-812 100, 200, 300, or 400 mg/day. Measurements included ADHD Rating Scale (RS)-IV total score and Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scores. Safety assessments included laboratory and electrocardiogram (ECG) measurements, suicidality monitoring (Columbia-Suicide Severity Rating Scale), and adverse event (AE) reporting. Results: Significant improvements in ADHD-RS-IV total score were observed for 200, 300, and 400 mg dose groups versus placebo (p <.05; effect size [ES] = 0.547, 0.596, and 0.623). CGI-I score for the 300 mg group and CGI-S score for all SPN-812 groups except for 100 mg improved significantly (p <.05) versus placebo. The most frequent AEs (≥15%) were somnolence, headache, and decreased appetite. Conclusion: SPN-812 significantly reduced the severity of ADHD symptoms and was well tolerated. The efficacy and safety of SPN-812 are being investigated in Phase III trials.",
keywords = "ADHD, attention deficit/hyperactivity disorder, nonstimulant, viloxazine",
author = "Johnson, {Janet K.} and Tesfaye Liranso and Keith Saylor and Gabriela Tulloch and Toyin Adewole and Stefan Schwabe and Azmi Nasser and Findling, {Robert L.} and Newcorn, {Jeffrey H.}",
note = "Funding Information: 348 358 {\textcopyright} The Author(s) 2019 2019 SAGE Publications This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( http://www.creativecommons.org/licenses/by-nc/4.0/ ) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage ). Objective: The objective of this study is to evaluate efficacy and safety of SPN-812 (extended-release viloxazine) for ADHD in children aged 6 to 12 years. Method: In an 8-week study, 222 participants were randomized to placebo or SPN-812 100, 200, 300, or 400 mg/day. Measurements included ADHD Rating Scale (RS)-IV total score and Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scores. Safety assessments included laboratory and electrocardiogram (ECG) measurements, suicidality monitoring (Columbia-Suicide Severity Rating Scale), and adverse event (AE) reporting. Results: Significant improvements in ADHD-RS-IV total score were observed for 200, 300, and 400 mg dose groups versus placebo ( p < .05; effect size [ES] = 0.547, 0.596, and 0.623). CGI-I score for the 300 mg group and CGI-S score for all SPN-812 groups except for 100 mg improved significantly ( p < .05) versus placebo. The most frequent AEs (≥15%) were somnolence, headache, and decreased appetite. Conclusion: SPN-812 significantly reduced the severity of ADHD symptoms and was well tolerated. The efficacy and safety of SPN-812 are being investigated in Phase III trials. attention deficit/hyperactivity disorder ADHD nonstimulant viloxazine Supernus Pharmaceuticals, Inc. typesetter ts1 Declaration of Conflicting Interests The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: J.K.J. is a former employee of Supernus Pharmaceuticals, Inc.; T.L. is an employee of Supernus Pharmaceuticals, Inc.; K.S. received clinical trial research support from Otsuka and Supernus Pharmaceuticals, Inc. and serves as a consultant and advisory board member for Supernus Pharmaceuticals, Inc.; G.T. is a former employee of Supernus Pharmaceuticals, Inc.; T.A. is an employee of Supernus Pharmaceuticals, Inc.; S.S. is an employee of Supernus Pharmaceuticals, Inc.; A.N. is an employee of Supernus Pharmaceuticals, Inc.; R.L.F. discloses past or present relationships with the following organizations in the past 24 months: Research support, and/or consultant, and/or speaker{\textquoteright}s bureau for Aevi, Akili, Alcobra, Amerex, American Academy of Child & Adolescent Psychiatry, Bracket, Daiichi Sankyo, ePharmaSolutions, Forest, Genentech, Ironshore, KemPharm, Lundbeck, U.S. National Institutes of Health, Neurim, Nuvelution, Otsuka, PCORI, Pfizer, Physicians Postgraduate Press, Roche, Shire, Sunovion, Supernus Pharmaceuticals, SyneuRx, Teva, Tris, TouchPoint, Validus; and received royalties from American Psychiatric Press and Sage. J.H.N. discloses the following relationships: Akili Interactive (consultant), Alcobra (consultant), Arbor (consultant), Cingulate Therapeutics (consultant), Enzymotec (consultant, research support), KemPharm (consultant), Lundbeck (consultant, research support), Medice (consultant), NLS Pharma (consultant), Pfizer (consultant), Rhodes (consultant), Shire (consultant, research support), Sunovion (consultant), and Supernus Pharmaceuticals Inc. (consultant). He received research support from Enzymotec, Lundbeck, and Shire. Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Editorial support was provided by IMPRINT Science, New York, NY, USA, with funding from Supernus Pharmaceuticals, Inc. Supplemental Material Supplemental material for this article is available online. Publisher Copyright: {\textcopyright} The Author(s) 2019.",
year = "2020",
month = jan,
day = "1",
doi = "10.1177/1087054719836159",
language = "English (US)",
volume = "24",
pages = "348--358",
journal = "Journal of Attention Disorders",
issn = "1087-0547",
publisher = "SAGE Publications Inc.",
number = "2",
}