Introduction

Eslicarbazepine acetate (ESL) is a once-daily (QD) oral antiepileptic drug (AED), approved by the US Food and Drug Administration for the treatment of partial-onset seizures (POS) as monotherapy or adjunctive therapy. ESL is approved by the European Medicines Agency as adjunctive therapy of POS in adults.

• ESL is rapidly and extensively metabolized to eslicarbazepine,1 which is thought to act primarily by preferentially stabilizing the inactivated state of voltage-gated sodium channels.
• The efficacy and safety of ESL monotherapy (1200 and 1600 mg QD) have been explored in two Phase III studies in patients with POS, which demonstrated superior efficacy to a historical control and a safety/tolerability profi le consistent with that reported for adjunctive ESL.3,4
• Here we report the development of a population pharmacokinetic (PK) model for eslicarbazepine during ESL monotherapy.

Poster originally presented at: American Epilepsy Society (AES) Annual Meeting: December 5-9, 2014, Seattle, WA. Encore presented at: American College of Clinical Pharmacology, September 27-29, 2015, San Francisco, CA.

By Bassel Abou-Khalil, Imran Ali, Aashit Shah, Jill Fiedler-Kelly, Elizabeth A Ludwig, Soujanya Sunkaraneni, David Blum