Drug updated on 6/25/2024
Dosage Form | Capsule (oral; serdexmethylphenidate/dexmethylphenidate: 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, 52.3 mg/10.4 mg) |
Drug Class | Central 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
- 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 Title | Year | Source |
---|---|---|
Azstarys (serdexmethylphenidate and dexmethylphenidate) Prescribing Information. | 2023 | Corium, Inc. Grand Rapids, MI |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
Analysis of growth velocity in children with attention-deficit/hyperactivity disorder treated for up to 12 months with serdexmethylphenidate/dexmethylphenidate. | 238Subjects F: 39% M: 61% | 2023 | Journal of Child and Adolescent Psychopharmacology |
Safety and tolerability of serdexmethylphenidate/dexmethylphenidate capsules in children with attention-deficit/hyperactivity disorder: a 12-month, open-label safety study. | 238Subjects F: 39% M: 61% | 2023 | Journal of Child and Adolescent Pharmacology |
A randomized, controlled laboratory classroom study of serdexmethylphenidate and d-methylphenidate capsules in children with attention-deficit/hyperactivity disorder. | 150Subjects F: 39% M: 61% | 2021 | Journal of Child and Adolescent Psychopharmacology |
Sex Distribution:
F:39%
M:61%
238Subjects
Year:
2023
Source:Journal of Child and Adolescent Psychopharmacology
Sex Distribution:
F:39%
M:61%
238Subjects
Year:
2023
Source:Journal of Child and Adolescent Pharmacology
Sex Distribution:
F:39%
M:61%
150Subjects
Year:
2021
Source:Journal of Child and Adolescent Psychopharmacology