Bial and Eisai said that Zebinix (eslicarbazepine acetate) as monotherapy has been confirmed in the Euro-Esli study to be significantly effective than the same drug as adjunctive therapy for focal-onset epilepsy in adults.
The confirmation came from the new sub-analysis data from the Euro-Esli study of eslicarbazepine acetate for focal-onset seizures in more than 2,000 patients.
Bial and Eisai said that the new results of eslicarbazepine acetate offer real-world substantiation for the value of the drug as monotherapy in newly diagnosed patients.
The companies said that data collected from the Euro-Esli study sub-analysis reveal that at 12 months, responder and seizure freedom rates were considerably higher in patients subjected to eslicarbazepine acetate monotherapy at the last visit in comparison to adjunctive therapy.
Significant differences were observed in several demographics and baseline characteristics between patients treated with eslicarbazepine acetate as monotherapy and those who were subjected to the drug as adjunctive therapy, said the companies.
Euro-Esli study sub-analysis author Martin Holtkamp said: “We are very encouraged by these results which demonstrate efficacy and tolerability of eslicarbazepine acetate monotherapy in patients with focal-onset seizures.
“These findings complement those found in the Phase III clinical trials, providing further evidence to confirm its effectiveness in a clinical practice setting.”
Eslicarbazepine acetate is an inhibitor of voltage-gated sodium channel. It has been designed to selectively target the slow inactivated state of the sodium ion channel.
The drug is indicated in the European Union (EU) as a monotherapy for partial-onset seizures, with or without secondary generalization, in adults with newly diagnosed epilepsy.
Eslicarbazepine acetate is also indicated as adjunctive therapy in the EU in adults, adolescents and children aged over 6 years, with partial-onset seizures with or without secondary generalization.
Currently, the epilepsy drug is being marketed by Bial and its licensee Eisai Europe in Europe and Russia under the trade name Zebinix or Exalief. In the US and Canada, the epilepsy drug is marketed under the trade name Aptiom by Sunovion Pharmaceuticals under an exclusive license from Bial.