Exposure-safety and efficacy response relationships and population pharmacokinetics of eslicarbazepine acetate

Authors: Gidal BE, Jacobson MP, Ben-Menachem E, Carreño M, Blum D, Soares-da-Silva P, Falcão A, Rocha F, Moreira J, Grinnell T, Ludwig EA, Fiedler-Kelly J, Passarell JA, Sunkaraneni S
Publication: Acta Neurol Scand
Keywords: antiepileptic, epilepsy, eslicarbazepine, pharmacodynamics, pharmacokinetics
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Objectives

Eslicarbazepine acetate (ESL) is a once-daily (QD) oral antiepileptic drug (AED) for focal-onset seizures (FOS). Pharmacokinetic (PK) and pharmacodynamic (PD) models were developed to assess dose selection, identify significant AED drug interactions, and quantitate relationships between exposure and safety and efficacy outcomes from Phase 3 trials of adjunctive ESL.

By Elizabeth A Ludwig, Jill Fiedler-Kelly, Julie A Passarell