Serdexmethylphenidate and dexmethylphenidate

(Azstarys®)

Serdexmethylphenidate and dexmethylphenidate

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Drug updated on 5/17/2024

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.

Summary
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  • Serdexmethylphenidate and dexmethylphenidate (Azstarys) is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 years of age and older. It has been shown to maintain its efficacy in reducing ADHD symptoms over a 12-month period, providing evidence of its potential as a reliable long-term treatment option.
  • The information was derived from three randomized controlled trial studies. These studies provided comprehensive analysis focusing on Azstarys' safety, effectiveness, and comparative analysis to other drugs within the context of treating ADHD.
  • In comparison with placebo during laboratory classroom studies, Azstarys significantly improved ADHD symptoms. This improvement was measured using the SKAMP Rating Scale and Permanent Product Measure of Performance (PERMP), indicating significant enhancement in attention and behavior throughout the day from 1 to 13 hours post-dose.
  • Regarding safety considerations, Azstarys was associated with modest reductions in expected weight gain, but these changes were not considered clinically significant, suggesting minimal impact on growth, which is an important consideration for pediatric populations.
  • Across all studies reviewed, common adverse events included decreased appetite, upper respiratory tract infection among others; however, no serious adverse events related to treatment were reported, nor any clinically significant changes observed in electrocardiograms or blood pressure, implying that it is well-tolerated by patients compared to other methylphenidate products.
  • While specific subgroups based on gender or race were not mentioned within these studies, they did focus primarily on children aged between six-twelve years old, offering valuable insights into how effective this drug can be when used amongst younger patient groups suffering from early onset ADHD.

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