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

ABSTRACT:

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.

Methods

Eslicarbazepine (the primary active metabolite of ESL) population PK was evaluated using data from 1351 subjects enrolled in 14 studies (11 Phase 1 and three Phase 3 studies) after multiple oral doses ranging from 400 to 1200 mg. Population PK and PD models related individual eslicarbazepine exposures to safety outcomes and efficacy responses.

Results

Eslicarbazepine PK was described by

SUBMITTER: Gidal BE 

PROVIDER: S-EPMC6099471 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature