Epilepsy drug receives approval as monotherapy from European Medicines Agency

Written by Lauren Pulling, Editor

Zebinix (eslicarbazepine acetate) has received approval from the European Medicines Agency as a once-daily monotherapy in adults with newly diagnosed partial-onset epilepsy. Eslicarbazepine acetate is already used in Europe as an adjunctive therapy in patients over 6 years of age with partial-onset seizures. Following the results of a Phase III trial, this latest approval of the drug as a monotherapy was announced by Bial (Porto, Portugal) and Eisai (Kamisu, Japan).
The Phase III, randomized, double-blind, active-controlled study compared once-daily eslicarbazepine acetate as a monotherapy with twice-daily, controlled-release carbamazepine in adults newly diagnosed with partial-onset seizures. The data demonstrated that 71.1% of eslicarbazepine acetate-treated patients (n=276/388) were seizure-free for 6 months or more, compared with 75.6% of the carbamazepine group, with these figures dropping to 64.7% and 70.3%, respectively, after 1 year.

Eslicarbazepine acetate, unlike other sodium channel blockers, selectively targets the slow inactive state of sodium ion channels, which has previously been implicated in epilepsy pathogenesis. The drug prevents the return of the channels to its active state, therefore reducing neuronal firing (based on animal data).

The recommended starting dose of eslicarbazepine acetate is 400 mg once daily, which should then be increased to 800 mg after 1–2 weeks. Researchers suggest that the dose could be increased up to 1600 mg daily, depending on individual response. Safety analysis of the Phase III study showed that the tolerability profile of eslicarbazepine acetate was similar to that of twice-daily controlled-release carbamazepine, with side effects mostly of mild intensity.

“This decision for eslicarbazepine acetate by the European Commission reinforces Eisai’s commitment to researching and developing neurological treatment options that have the potential to help people manage epilepsy more effectively. This milestone means that newly-diagnosed adult patients in Europe who experience partial-onset epilepsy will now have a broader range of treatment options available,” commented Neil West, Vice President EMEA, Global Neurology Business Unit at Eisai.

Source: www.prnewswire.co.uk/news-releases/european-commission-grants-marketing-authorisation-for-zebinix-eslicarbazepine-acetate-as-once-daily-623720064.html