AZSTARYS FDA Indications
AZSTARYS (serdexmethylphenidate and dexmethylphenidate) is FDA-approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older. 1
Specific Indication Details
- Age range: Approved for patients ≥6 years of age 1
- Condition: Attention Deficit Hyperactivity Disorder (ADHD) 1
- Drug classification: Central nervous system (CNS) stimulant 1
Clinical Context and Evidence Base
AZSTARYS fits within the FDA-approved stimulant medication class recommended as first-line pharmacological treatment for elementary and middle school-aged children (6-12 years) with ADHD. 2
Supporting Efficacy Data
In a randomized, double-blind laboratory classroom study of children ages 6-12 with ADHD, SDX/d-MPH demonstrated significant improvement in ADHD symptoms compared with placebo (p < 0.001), with a rapid onset (0.5 hours) and extended duration of treatment effect (up to 13 hours post-dose) 3
A 12-month open-label safety study in 238 children aged 6-12 years demonstrated that SDX/d-MPH was safe and well tolerated, with no unexpected safety findings compared to other methylphenidate products 4
The most common treatment-emergent adverse events were decreased appetite (18.5%), upper respiratory tract infection (9.7%), nasopharyngitis (8.0%), decreased weight (7.6%), and irritability (6.7%) 4
Important Caveats
AZSTARYS is NOT FDA-approved for preschool-aged children (4-5 years), as methylphenidate use in this age group remains off-label despite moderate evidence for safety and efficacy 2
Growth effects were minimal and not clinically significant over 12 months of treatment, with mean Z-score changes from baseline of -0.20 for weight and -0.21 for height (changes <0.5 SD are not considered clinically significant) 5