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