Citation

Johnson JK, Liranso T, Saylor K, Tulloch G, Adewole T, Schwabe S, Nasser A, Findling RL, Newcorn JH. J. Atten. Disord. 2020; 24(2): 348-358.

Copyright

(Copyright © 2020, SAGE Publishing)

DOI

10.1177/1087054719836159

PMID

30924702

PMCID

PMC6939319

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.

Language: en

Keywords

Humans; Child; Treatment Outcome; Double-Blind Method; ADHD; Dose-Response Relationship, Drug; Delayed-Action Preparations; viloxazine; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Viloxazine; attention deficit/hyperactivity disorder; nonstimulant