Zebinix® (eslicarbazepine acetate) Receives Positive CHMP Opinion as Once-daily Monotherapy for Newly Diagnosed Focal-onset Epilepsy

PORTO, Portugal and HATFIELD, England, March 28, 2017 /PRNewswire/ --

FOR EMEA MEDIA ONLY - NOT FOR SWISS/AUSTRIAN JOURNALISTS

Efficacy and safety/tolerability of once-daily eslicarbazepine acetate in the monotherapy setting demonstrated in a Phase III, double-blind, active-controlled trial^[1],[2]

Bial and Eisai today announce that Zebinix^® (eslicarbazepine acetate) has received a positive opinion for use as a once-daily monotherapy to treat adults with newly-diagnosed focal onset epilepsy from The European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP).

Eslicarbazepine acetate is currently indicated in Europe as adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset (focal) seizures with or without secondary generalisation.^[3]

The CHMP based its decision on positive results from a Phase III study in a monotherapy setting which showed that eslicarbazepine acetate was proven to be non-inferior to controlled-release carbamazepine in patients with newly diagnosed focal onset seizures.^[1],[4]

The Phase III, randomised, double-blind, active-controlled, non-inferiority study^[1] (Study 311) compared once-daily eslicarbazepine acetate as monotherapy treatment for newly diagnosed adults with focal-onset seizures to twice-daily, controlled-release carbamazepine. The primary endpoint was the proportion of patients seizure-free for the entire 26-week evaluation period.^[1]

815 eligible patients were randomised for the trial. In the per-protocol (PP) population (n=785), seizure freedom rates with eslicarbazepine acetate were similar to those observed with controlled-release carbamazepine in eligible patients. The data show that 71.1% (n=276) of patients for eslicarbazepine acetate and 75.6% (n=300) of patients for controlled-release carbamazepine were seizure-free for six months or more, at the last evaluated dose (average risk difference -4.28%, 95% CI -10.3, 1.74%). The one-year seizure-freedom rate at the last evaluated dose was 64.7% (n=251) on eslicarbazepine acetate and 70.3% (n=279) on controlled-release carbamazepine (average risk difference: -5.46%; 95%CI: -11.88, 0.97%).^[1]