Serdexmethylphenidate and dexmethylphenidate

(Azstarys®)

Serdexmethylphenidate and dexmethylphenidate

Drug updated on 9/4/2024

Dosage FormCapsule (oral; serdexmethylphenidate/dexmethylphenidate: 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, 52.3 mg/10.4 mg)
Drug ClassCentral nervous system stimulants
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 years of age and older.

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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.

Product Monograph / Prescribing Information

Document TitleYearSource
Azstarys (serdexmethylphenidate and dexmethylphenidate) Prescribing Information. 2023Corium, Inc. Grand Rapids, MI

Randomized Controlled Trials


Sex Distribution:

F:39%
M:61%
238Subjects

Year:

2023

Source:Journal of Child and Adolescent Psychopharmacology


Sex Distribution:

F:39%
M:61%
150Subjects

Year:

2021

Source:Journal of Child and Adolescent Psychopharmacology