Drug updated on 3/28/2024
| 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.
Summary
- Serdexmethylphenidate and dexmethylphenidate (Azstarys) is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 years of age and older.
- Three randomized controlled trials were reviewed to gather information about Azstarys, focusing on its safety, efficacy, and impact on growth in children with ADHD.
- A post hoc analysis from a 12-month open-label safety study showed that long-term treatment with Azstarys resulted in modest reductions in expected weight gain and lower-than-expected increases in height among children aged 6-12 years; however, these changes were not considered clinically significant as they plateaued or diminished later during the course of treatment.
- In another one-year study assessing daily oral administration of Azstarys among children aged 6-12 years old with ADHD, it was found to be safe and well-tolerated compared to other methylphenidate products; common adverse events included decreased appetite, upper respiratory tract infection, nasopharyngitis, decreased weight loss,and irritability but none led to discontinuation due to lack of clinical significance.
- The same year-long trial also demonstrated sustained efficacy throughout the duration based on assessments using ADHD Rating Scale-5 (ADHD-RS-5) and Clinical Global Impressions Severity scale which showed overall reductions in symptoms severity over time indicating potential benefits for long term use.
- A double-blind dose optimized laboratory classroom study revealed that once-daily serdexmethylphenidate/dexmethylphenidate capsules significantly improved SKAMP-combined scores averaged over a day when compared against placebo showing rapid onset extended duration effect making it an effective choice for managing symptoms associated with ADHD within this population group while maintaining acceptable levels of safety profile.
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