Perampanel oral suspension pharmacokinetics evaluated in pediatric epilepsy patients aged 1 month to 4 years

Epilepsy in infants and young children presents significant treatment challenges, often requiring precise dosing and flexible formulations due to rapid developmental changes and difficulties with solid oral medications. Current antiepileptic drugs may lack suitable pediatric formulations, leading to off-label use or compounding, which can compromise dose accuracy and adherence. Perampanel is an established antiepileptic drug, and an oral suspension formulation could greatly improve administration and therapeutic outcomes in this vulnerable population. Characterizing its pharmacokinetics in very young children is crucial for safe and effective dosing, addressing a critical gap in pediatric epilepsy management.

This study aimed to characterize the pharmacokinetics (PK) of perampanel oral suspension when administered as adjunctive therapy. Pediatric participants, specifically those from 1 month to less than 4 years of age with epilepsy, were enrolled. The primary objective was to evaluate the PK profile of perampanel during the Maintenance Period of a larger Core Study. This involved assessing how the drug is absorbed, distributed, metabolized, and excreted in this young population following oral suspension administration. The study design focused on understanding drug exposure and variability to inform appropriate dosing strategies.