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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 a one‐compartment model with linear absorption and elimination. The probability of a treatment‐emergent adverse event ( TEAE ; dizziness, headache, or somnolence) was higher with an initial dose of  ESL  800 mg than with an initial dose of  ESL  400 mg  QD . Body weight, sex, region, and baseline use of carbamazepine ( CBZ ) or lamotrigine were also found to influence the probability of  TEAE s. Eslicarbazepine exposure influenced serum sodium concentration, standardized seizure frequency, and probability of response; better efficacy outcomes were predicted in patients not from Western Europe ( WE ; vs  WE  patients) and those not taking  CBZ  (vs taking  CBZ ) at baseline.    Conclusions  Pharmacokinetic and  PK / PD  modeling were implemented during the development of  ESL  for adjunctive treatment of  FOS  in adults. This quantitative approach supported decision‐making during the development of  ESL , and contributed to dosing recommendations and labeling information related to drug interactions.

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