Drug updated on 9/4/2024
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
- 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 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