Summary

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• This summary is based on the review of three systematic review(s)/meta-analysis(es). ^[1-3]
• Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Reduction: SPN-812 (viloxazine) demonstrated superior efficacy in reducing ADHD symptoms compared to placebo across multiple doses (100, 200, 300, and 400 mg/d). Patients in the SPN-812 groups had significantly greater reductions in ADHD-RS-5 scores (p < 0.05) and a higher response rate (relative risk (RR) = 1.62, 95% confidence interval (CI) = 1.36-1.93).
• Clinical Global Impression-Improvement (CGI-I) and Functional Outcomes: SPN-812 significantly improved CGI-I scores (RR = 1.53, 95% CI = 1.32-1.78), and better outcomes were also observed in the Weiss Functional Impairment Rating Scale-Parent (WFIRS-P) and Conners 3-Parent Short Form (Conners 3-PS) scores (p < 0.05) compared to placebo.
• Efficacy Across Age Groups: The studies included pediatric patients aged 6-17 years, with both children and adolescents benefiting from the treatment. There was no significant difference in efficacy across these age groups.
• Adverse Events (AEs): A higher proportion of patients in the viloxazine group experienced at least one AE compared to placebo (RR = 1.52; 95% CI = 1.24-1.85; p < .0001), with somnolence being notably more frequent (RR = 3.93; 95% CI = 2.11-7.31; p < .0001). Decreased appetite was also reported, except in the SPN-812 300 mg/d dose group.
• Serious Adverse Events (SAEs): There was no statistically significant difference in the incidence of SAEs between SPN-812 and placebo groups, and while the viloxazine group had a higher incidence of SAEs, this was not statistically significant (RR = 2.98; 95% CI = .67-13.3; p = .15).