Bial has unveiled positive results for a pivotal phase 3 non-inferiority study comparing the efficacy and safety of eslicarbazepine acetate (ESL) to controlled release carbamazepine (CBZ-CR) as monotherapy in newly diagnosed adult patients with partial-onset seizures (POS).
Bial director of research & development department Patrício Soares-da-Silva said: "The study met its primary endpoint, which was the proportion of seizure-free patients for six consecutive months under monotherapy treatment. This is an important addition to the well-known value of ESL as adjunctive therapy.
"The complete study results will shortly be disclosed at major neurology and epilepsy conferences and published in specialized journals in the field..
"The efficacy of ESL was clearly demonstrated in a high proportion of patients that remained seizure-free for six consecutive months, which was non-inferior to the seizure-free rate observed in patients treated with CBZ-CR, positioning ESL as a first-line treatment for newly diagnosed patients with focal epilepsies.", said Professor Eugen Trinka, principal study coordinator and ?Chairman of the Department of Neurology, Paracelsus Medical University, CDK, Salzburg, Austria.
"This study reflects our commitment to the development of new treatment options for people living with focal epilepsies", said António Portela, CEO of Bial Group.
This pivotal phase 3 study was a randomised, double-blind, parallel-group, active-controlled and non-inferiority study, investigating the efficacy and safety of once-daily ESL (800 to 1600 mg/daily) as monotherapy treatment for newly diagnosed adults with partial-onset seizures in comparison with twice-daily CBZ-CR (400 to 1200 mg/daily).
Based on these results, Bial intends to submit in the second quarter of 2016 a variation file to the European Medicines Agency (EMA), to expand the marketing authorization of eslicarbazepine acetate (ESL) as monotherapy in adults with partial-onset seizures.
ESL is currently approved by the European Medicines Agency (tradename Zebinix). Eslicarbazepine acetate is indicated as adjunctive therapy in adults with partial onset seizures, with or without secondary generalisation.
ESL is also approved by the US Food and Drug Administration (tradename Aptiom) for the treatment of POS as monotherapy or adjunctive therapy.