Bial’s epilepsy drug shows clinical efficacy in real-life study

Bial and its licensee Eisai have reported positive real-life data of Zebinix (eslicarbazepine acetate) from the Euro-Esli study in patients with partial-onset seizures (POS).

Eslicarbazepine acetate is a voltage-gated sodium channel blocker being developed to selectively target the slow inactivated state of sodium ion channel.

Supporting the results obtained during clinical trials, the new data confirmed Zebinix’s effectiveness and tolerability with seizure freedom in 41.3% of patients at 12 months and 73.4% retention rates.

The Euro-Esli study involved exploratory pooled analysis of data from 14 European clinical practice studies of 2,058 adults aged 14 to 88 with POS, with or without secondary generalisation.

Retention and effectiveness were evaluated through percentage reduction from baseline in monthly seizure frequency, responder rate and seizure freedom rate following three, six and 12 months of treatment.

Additionally, the study monitored safety and tolerability based on adverse events (AEs).

The data indicated a significant decrease in monthly frequencies of total, simple partial, complex partial and secondarily generalised seizures from baseline to final visit.

While 34% of patients experienced adverse events during the study, 13.6% were discontinued as a result.

Bial CEO António Portela said: "These results improve our knowledge and understanding around the use of eslicarbazepine acetate in routine clinical practice and strengthen Bial's commitment to developing and delivering beneficial treatment options for people living with epilepsy.”

Indicated as monotherapy for POS with or without secondary generalisation, eslicarbazepine acetate is currently marketed by Bial and Eisai Europe under the trade name Zebinix, or Exalief in Europe and Russia.

With an exclusive licence from Bial, Sunovion Pharmaceuticals markets the drug in the US and Canada under the trade name Aptiom.