Comparative Pharmacology
Head-to-head clinical analysis: AZSTARYS versus DYANAVEL XR 15.
Peer-Reviewed Evidence
Head-to-head clinical analysis: AZSTARYS versus DYANAVEL XR 15.
AZSTARYS vs DYANAVEL XR 15
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
AZSTARYS is a prodrug of dexmethylphenidate, a central nervous system stimulant. The exact mechanism of action in attention deficit hyperactivity disorder (ADHD) is unknown, but it is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron, increasing their levels in the extraneuronal space.
Dyanavel XR contains amphetamine, which is a central nervous system stimulant that increases synaptic concentrations of dopamine and norepinephrine by inhibiting their reuptake and promoting their release from presynaptic terminals.
Initial: 39.2 mg oral once daily in the morning; titrate weekly by 19.6 mg increments as needed; maximum dose: 78.4 mg once daily.
1-3 capsules orally once daily in the morning. Each capsule contains 15 mg of amphetamine (equivalent to 15 mg dextroamphetamine/amphetamine).
None Documented
None Documented
Serdexmethylphenidate: 1.5 hours; dexmethylphenidate: 3.5 hours. The terminal half-life of total dexmethylphenidate after AZSTARYS is approximately 6.5 hours, supporting once-daily dosing.
Terminal elimination half-life: amphetamine (d-isomer) 9-11 hours, l-isomer 11-14 hours; allows for once-daily dosing in extended-release formulation
Renal: 90% (primarily as metabolites, with 50-70% as the major metabolite (-)-phensuximide glucuronide). Fecal: <5%.
Renal (80-90% as unchanged drug and metabolites, primarily dehydro-amphetamine); fecal excretion minimal (<5%)
Category C
Category C
CNS Stimulant
CNS Stimulant