Aptiom Promising as Monotherapy for Partial Onset Seizures

FDA is reviewing a supplemental new drug application to expand the indication for eslicarbazepine acetate (ESL) as a monotherapy.

WASHINGTON — For patients with partial onset seizures who were not responding to existing treatment with one to two existing antiepileptic drugs, monotherapy with once-daily eslicarbazepine acetate (ESL) resulted in better seizure-related exit rates and improved quality-of-life scores, findings from several studies indicate.

Eslicarbazepine acetate (Aptiom, Sunovion) is currently indicated as an add-on therapy for patients with partial onset seizures, but data presented at the American Academy of Neurology 2015 meeting suggests it may offer advantages as monotherapy.

“Partial onset seizures affect more than 2 million people in the United States, yet about 30% of these patients do not have their seizures controlled,” said Fred Grossman, DO, FAPA,  head of Global Clinical Development and Medical Affairs at Sunovion. “We see significant differences between patients who are on monotherapy and those on multiple antiepileptic drugs [AEDs] in terms of quality of life. This is a significant unmet medical need.”

In a poster session, researchers presented data on the safety and efficacy of ESL after conversion as an adjunctive therapy to monotherapy in two identically designed phase-3 studies.

Overall, 332 adult patients who weren’t responding to treatment with up one to two AEDs were enrolled. The data presented were from two 18-week double-blind, randomized phase-3 conversion-to-monotherapy studies in to evaluate the efficacy and safety of once-daily ESL 1,200 mg or 1,600 mg.

Estimated seizure-related exit rates, which signify worsening condition, were 30.8% (95% CI: 23.0-40.5%) in the ESL 1,200 mg group, and 20.6% (95% CI: 15.6-26.8%) in the ESL 1,600 mg group — both less than the lower limit of the prediction interval calculated from the historical control (65.3%), the researchers found.

“Data from our monotherapy clinical trials build upon the established efficacy and safety of [ESL] adjunctive treatment and may provide a potential new option for patients with epilepsy who could benefit from monotherapy,” Grossman said.

A supplemental new drug application to expand ESL’s indication from adjunctive to monotherapy is currently under review with the FDA.

Additional ESL mono therapy data were presented as part of two separate poster sessions at meeting, covering topics including improved quality of life and depressive symptoms and lower abuse potential.


  1. Pazdera L et al. #P1.250. “Eslicarbazepine Acetate (ESL) Monotherapy in Adults with Partial-Onset Seizures (POS): an Analysis of Pooled Data from Two Phase III Studies, with Use of a Historical Control.”
  2. Gilliam F et al. #P1.234. “Changes in Quality of Life (QoL) and Depressive Symptoms in a Long-term Open-label Extension (OLE) of Eslicarbazepine Acetate (ESL) Monotherapy Studies in Adults with Refractory Partial-onset Seizures (POS).”
  3. Gidal B et al. #P1.233. “Abuse Potential of Antiepileptic Drugs: a Review Using the VigiBaseTM Pharmacovigilance Database.”

All presented at: AAN 2015. April 18-25, 2015; Washington, D.C.

Disclosures: The Sunovion Pharmaceuticals Inc. provided funding for the studies.