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

Porto, Portugal and Hatfield, England (ots/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]

"This CHMP decision, with the promise it brings of a new treatment
option for patients is very welcome. Around 60 per cent of patients
with epilepsy have focal seizures, and we also know that adherence to
treatment is better with a once-daily monotherapy." explains Eugen
Trinka, Professor and Chair of Department of Neurology, Christian
Doppler Klinik, Paracelsus Medical University, Salzburg, Austria.

"This is important news for people with focal epilepsy who may now