Summary

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• Azstarys (serdexmethylphenidate and dexmethylphenidate) is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 years of age and older.
• This summary is based on the review of three randomized controlled trial(s). ^[1-3]
• In the 12-month open-label safety study, the mean Z-score changes for weight and height in children aged 6-12 years with ADHD were -0.20 and -0.21, respectively, indicating no clinically significant impact on growth as these changes were less than 0.5 SD.
• In a randomized, double-blind, dose-optimized study, SDX/d-MPH significantly improved SKAMP-Combined scores compared to placebo, with a least-squares mean treatment difference of -5.41 (p < 0.001) and significant effects observed 1 to 10 hours postdose.
• In a dose-optimized open-label study, SDX/d-MPH showed sustained reductions in ADHD symptoms and severity over a one-year treatment period, indicating continued efficacy throughout the duration of the study.
• The overall effects of SDX/d-MPH on growth velocity in children aged 6-12 years with ADHD were minimal and not clinically significant. 7. 60.1% of subjects experienced at least one treatment-emergent adverse event (TEAE), with common TEAEs including decreased appetite (18.5%), upper respiratory tract infection (9.7%), and nasopharyngitis (8.0%). No clinically meaningful trends in electrocardiograms, cardiac events, or blood pressure events were observed, and no discontinuations were reported.
• No serious adverse events were reported; the most common adverse events during the Dose Optimization Phase were insomnia and decreased appetite, with a safety profile comparable to other stimulant treatments.
• There is no population types or subgroups information available in the reviewed studies.