Summary

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• This summary is based on the review of two randomized controlled trial(s). ^[1-2]
• In a study evaluating SDX/d-MPH (Azstarys) in children aged 6-12 years with attention-deficit/hyperactivity disorder (ADHD), significant improvements in ADHD symptoms were observed using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) and Permanent Product Measure of Performance (PERMP) scales, with a mean treatment difference in SKAMP-Combined scores of -5.41 (95% confidence interval (CI): -7.10 to -3.71; p < 0.001). Significant treatment effects were noted from 1 to 10 hours postdose, and a post hoc analysis suggested a duration of efficacy lasting up to 13 hours.
• The study demonstrated a sustained reduction in ADHD symptoms over a 1-year period, with improvements in ADHD-RS (response scale)-5 and Clinical Global Impressions (CGI)-S scores. The treatment’s efficacy was comparable to other methylphenidate products. The study population consisted of children aged 6-12 years.
• In one study, 60.1% (143/238) of participants experienced treatment-emergent adverse events (TEAEs), with the majority being mild to moderate in severity. Common TEAEs included decreased appetite (18.5%), upper respiratory tract infection (9.7%), and nasopharyngitis (8.0%). Serious adverse events were rare, occurring in two subjects, and were unrelated to the treatment. No significant cardiovascular safety concerns were reported.
• In another study, two-thirds of participants reported adverse events, with common events including insomnia and decreased appetite. No serious adverse events were observed during the dose optimization phase. The overall safety profile was consistent with other stimulant treatments for ADHD.
• The studies included children aged 6-12 years with ADHD, demonstrating sustained efficacy and safety over a 1-year treatment period. Significant improvements in ADHD symptoms were observed in this population, with a rapid onset of effect lasting up to 13 hours. The safety profile, which was consistent with other stimulant treatments, showed that the most common adverse events were decreased appetite and insomnia, with no unexpected safety concerns.