The US Food and Drug Administration (FDA) has approved a new, once-daily oral stimulant medication for treatment of attention deficit hyperactivity disorder (ADHD) in people aged 6 years and older. The new drug consists of a novel prodrug, serdexmethylphenidate, co-formulated with immediate-release d-methylphenidate. AZSTARYS (formally KP415) contains 30% immediate-release d-methylphenidate and 70% extended-release novel serdexmethylphenidate, a prodrug of d-methylphenidate. Serdexmethylphenidate is not active until after it has been absorbed by the lower intestinal tract and converted to d-methylphenidate.
The approval was based on a multicenter, double-blind, randomized, placebo-controlled, laboratory classroom phase 3 study. The study included 150 children aged 6 to 12 years diagnosed with ADHD. The primary endpoint measured the change from baseline in Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale – Combined (SKAMP-C) scores averaged over 13 hours. The SKAMP-C scale is a measure intended to assess functional impairment related to attention deficit hyperactivity disorder: the lower the score, the better. In clinical trials, SKAMP is assessed by trained clinicians in laboratory classrooms. The study met the primary endpoint. The least-squares mean post-dose SKAMP-C difference from baseline (150 subjects) was higher for the placebo group than for AZSTARYS group (0.54 vs. -4.87, respectively, p<0.001), with an average SKAMP-C score reduction of -5.4 points more in the AZSTARYS group [95% CI: (-7.1, -3.7)]. Adverse events seen more often with AZSTARYS than placebo were headache (5.4% vs. 1.3%), upper abdominal pain (4.1% vs. 1.3%), insomnia (2.7% vs. 1.3%) and pharyngitis (2.7% vs. 0%). No serious adverse events were reported.
AZSTARYS will be available in three once-daily dosage strengths of serdexmethylphenidate/dexmethylphenidate: 26.1 / 5.2 mg, 39.2 / 7.8 mg, and 52.3 / 10.4 mg. AZSTARYS is administered orally once daily in the morning with or without food, and the capsules may be taken whole, or opened and the entire contents sprinkled into 50 mL of water or over 2 tablespoons of applesauce.
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