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Zebinix® (Eslicarbazepine acetate) - Epilepsy treatment in adult patients

BIAL - Portela & Cª, S.A.
Project classification

Scientific area

3.1 Basic medicine

Discipline(s)

Neurosciences (including psychophysiology)

Project description

Project title

Zebinix® (Eslicarbazepine acetate) - Epilepsy treatment in adult patients

Scientific Coordinator's name:

Prof. Patrício Soares-da-Silva

Scientific Coordinator's e-mail:

psoares.silva@bial.com

Principal R&D Unit:

Prof. Patrício Soares-da-Silva

Other R&D Units involved in the project:

Other R&D units involved in the project

Project keyword(s)

Eslicarbazepine acetate, Epilepsy, Adjunctive therapy

Short abstract and comments

Zebinix® (EU trade name for eslicarbazepine acetate, development code BIA 2-093) is a once daily antiepileptic drug approved in April 2009 by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) as adjunctive therapy in adults with partial-onset seizures with or without secondary generalization. The safety and efficacy of Zebinix® as add-on therapy to 1-3 baseline antiepileptic drugs has been shown in three phase III double-blind, randomised placebo-controlled trials, involving 1049 patients with partial-onset seizures, enrolled by 125 centres, in 23 countries. In the open-label extensions of these studies (1 year follow-up), Zebinix® demonstrated significant sustained improvements in seizure frequency, reduced depressive symptoms, and significantly improved scores in health related quality of life. Currently trial BIA 2093-304 is ongoing in 228 sites distributed within US, Canada, Europe, South Africa, Asia Pacific and South America, to evaluate the efficacy of eslicarbazepine acetate administrated once daily at doses of 800 mg and 1200 mg compared with placebo as adjunctive therapy in patients with refractory partial epilepsy over a 12 week maintenance period.

Potential uses/indications

Adjunctive therapy in adults with partial-onset seizures with or without secondary generalization.

Status

Ongoing

Partner Status: Seeking Partners?

No

Grant number (QREN, FP7, Eureka, etc)

QREN 4859

Last edited on

2011-11-09 13:06:03

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