Eisai expects to launch epilepsy pill Zebinix across EU during 2009 -10

Once-daily eslicarbazepine (Zebinix) pill from Eisai gets EU approval to treat epilepsy.

Eslicarbazepine acetate (Zebinix) has been approved as once daily pill to treat epilepsy by  the European Commission.

Zebinix is developed by Bial-Portela and Eisai Europe. EC has approved eslicarbazepine acetate (Zebinix) as add-on (adjunctive) therapy in adults with partial-onset seizures, with or without secondary generalisation.

“The EU approval of Zebinix represents a significant milestone for Bial in our efforts to bring this novel treatment to patients with partial-onset seizures”, said Luà s Portela, president and chief executive officer of Bial. “We will work closely with our European partner Eisai to launch Zebinix across the EU during 2009 and into 2010.”

Eslicarbazepine acetate’s (Zebinix) efficacy, safety and tolerability has been demonstrated in three phase III double-blind, randomised placebo-controlled trials involving 1,049 patients with partial onset seizures. For each randomised control trial, patients were given the option of entering a one year open label extension study.

New Epilepsy pill: Effect and side effects

Eslicarbazepine acetate reduced epileptic seizure frequency significantly on a sustained basis. There were also considerable increases in responder rates (greater than or equal to 50% decrease in seizure frequency.) These studies also demonstrated that epileptic patients continued to take ESL with retention rates ranging from 68-79% at one year. The median daily dose of Eslicarbazepine acetate throughout this one year treatment was 800mg. Eslicarbazepine acetate treatment showed adverse events affecting more than 10% of patients in the pivotal studies, such as dizziness, headache and somnolence.

Eslicarbazepine acetate studies also improved scores of health related quality of life measures such as reduced ’seizure worry’, improvements in ‘cognitive functioning’ and reduced ‘medication effects’, all factors which significantly affect the lives of patients living with epilepsy.

How does Zebinix work?

Eslicarbazepine acetate (Zebinix) can be given as a true one tablet once a day regimen. Eslicarbazepine acetate works by selectively inhibiting the rapid firing of neurones. It interacts with site two of the voltage-gated sodium channel, stabilising its inactive form and preventing its return to the active open state, thereby reducing repetitive neuronal firing. Eslicarbazepine acetate has a much higher affinity for the inactivated state of the channel compared with the resting state which means it is less likely to interfere with normal neuronal function.

Zebinix epipepsy pill – availability in Europe

Under the terms of a deal with Bial, Eisai received a sole license to market, promote and distribute ESL within Europe, ie., Austria, Belgium, Bulgaria, Czech Republic, Belarus, Bosnia, Croatia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Monaco, Netherlands, Norway, Poland, Romania, Russia, Serbia, Slovakia, Slovenia, Spain (co promotion with Bial from launch) Sweden, Switzerland, Turkey, Ukraine and United Kingdom.

What are partial-onset seizures? 

Epilepsy is one of the most common neurological diseases, affecting approximately 1 in 100 people. Epilepsy is a chronic neurological disease characterised by abnormal discharges of neuronal activity causing seizures. Clinically, these manifest as convulsions or jerking of muscles.

Epileptic seizures may be limited to one part of the body, or may be generalised to involve the whole body. Epilepsy patients may also experience abnormal sensations, altered behaviour or altered consciousness. Epilepsy is a disorder with many possible causes. Often the cause of epilepsy is unknown. However, anything that disturbs the normal pattern of neuron activity – from illness to brain damage to abnormal brain development, can lead to seizures.

Epilepsy is characterised by abnormal firing of impulses from nerve cells in the brain. In partial-onset seizures, these bursts of electrical activity are initially focused in specific areas of the brain, but may become more generalised; the symptoms vary according to the affected areas. Nerve impulses are triggered via voltage-gated sodium channels in the nerve cell membrane. 

Treatment of partial-onset epileptic seizures, the most common type of epilepsy, presents a constant challenge – up to 40% of patients with partial-onset seizures do not achieve seizure control with current anti-epileptic drugs.

Adverse events, such as light-headedness (dizziness), somnolence (sleepiness), and cognitive slowing, are highly prevalent with existing anti-epileptic agents and may affect as many as 97% of patients. Hence, there is a need for new anti-epileptic agents that offer effective reduction in seizure frequency combined with a favourable safety profile.

Founded in 1924, Bial is the largest Portuguese pharmaceutical company and is based in S. Mamede do Coronado. Bial’s  products are available in over 30 countries throughout four continents. Key research areas for BIAL are the central nervous system, the cardiovascular system and allergology.

Eisai is one of the worlds leading R&D-based pharmaceutical companies. Eisai concentrates its R&D activities in three key areas: Alzheimer’s disease, multiple    sclerosis, neuropathic pain, epilepsy, depression, tumour regression, tumour suppression, antibodies, pain relief, nausea, acute coronary syndrome, atherothrombotic disease, sepsis, rheumatoid arthritis, psoriasis, Crohn’s disease, etc

In Europe, Eisai undertakes sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Iceland, Czech Republic, Hungary, and Slovakia.