Relationship Between Eslicarbazepine Exposure and Safety Endpoints for Eslicarbazepine Acetate Adjunctive Therapy

Authors: Penovich P, Krauss G, Sperling MR, Striano S, Elger C, Passarell JA, Fiedler-Kelly J, Ludwig EA, Sunkaraneni S, Sousa R, Rocha F, Blum D
Conference: American Epilepsy Society (AES)
Keywords: AED, eslicarbazepine, neurology
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Introduction

  • Eslicarbazepine acetate (ESL) is a once-daily (QD) oral antiepileptic drug (AED), approved in the US, Canada and the EU as adjunctive treatment of partial-onset seizures (POS).
  • After oral administration, ESL is extensively and rapidly converted to its major active metabolite, eslicarbazepine.1
  • Data from three randomized controlled Phase III trials (studies 2093-301, -302 and -304) showed that adjunctive ESL (400–1200 mg QD) was generally well tolerated by patients with POS.2
  • The current analysis uses data from the above studies to examine the relationship between eslicarbazepine exposure and the incidence of the most frequently occurring treatment-emergent adverse events (TEAEs) during adjunctive use of ESL.

American Epilepsy Society (AES) Annual Meeting, December 5-9, 2014, Seattle, WA

By Patricia Penovich, Gregory Krauss, Michael R. Sperling, Salvatore Striano, Christian Elger, Julie A Passarell, Jill Fiedler-Kelly, Elizabeth A Ludwig, Soujanya Sunkaraneni, Rui Sousa, Francisco Rocha, David Blum