Pharmaceutical companies Eisai and Bial have announced that clinical practice data from a sub-analysis of the Euro-Esli study found that Zebinix monotherapy has greater effectiveness compared with Zebinix as a combination therapy.
The exploratory and retrospective Euro-Esli study evaluated Zebinix in more than 2,000 adult patients with focal-onset epilepsy. It analysed pooled data from clinical practice studies in Europe to assess the safety, tolerability and effectiveness of the drug as an adjunctive treatment.
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The data was published in the Acta Neurologica Scandinavica journal.
Comprising eslicarbazepine acetate, Zebinix is a voltage-gated sodium channel blocker designed to selectively target slow or inactive sodium ion channels. The drug is indicated in the EU as a monotherapy for partial-onset seizures with or without secondary generalisation in adults with newly diagnosed epilepsy.
Zebinix is also indicated in the EU as an adjunctive therapy to treat adults, adolescents and children aged above six years with partial-onset seizures with or without secondary generalisation.
Effectiveness was evaluated after three, six and 12 months of Zebinix treatment and at final follow-up. Safety and tolerability were investigated for the duration of treatment.
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By GlobalDataAt 12 months, responder and seizure freedom rates were observed to be 93.2% and 77.4%, respectively, in patients treated with Zebinix monotherapy compared with 70.4% and 25.9% in the adjunctive therapy arm.
The Euro-Esli study’s sub-analysis author professor Martin Holtkamp said: “We are very encouraged by these results, which demonstrate efficacy and tolerability of Zebinix 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.”
In Europe and Russia, Zebinix is marketed by Bial and licenced by Eisai Europe.
Under an exclusive license from Bial, Sunovion Pharmaceuticals markets the drug in the US and Canada with the trade name Aptiom.
