One-a-day epilepsy pill eslicarbazepine acetate (Zebinix) launched in UK

Eslicarbazepine acetate (Zebinix), a once-daily pill to treat epileptic seizures  by Eisai has been launched in UK.

Eslicarbazepine acetate (Zebinix) is to be used as adjunctive therapy in adults with partial-onset seizures, with or without secondary generalisation.

Eslicarbazepine acetate (Zebinix) is developed from carbamazepine, the current ‘gold standard’ treatment against seizures from epilepsy.

Carbamazepine was launched in 1965.

Eslicarbazepine acetate is a voltage gated sodium channel blocker that has a higher affinity for the inactivated state of the channel compared with the resting state. This suggests an enhanced inhibitory selectivity for rapidly firing neurons over those displaying normal activity.

Eslicarbazepine acetate has been developed to avoid formation of the epoxide metabolite which has been associated with neurological side effects, Eisai sated in a press release.

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

Eslicarbazepine acetate demonstrated significant and sustained reductions in seizure frequency and significant increases in responder rates. These studies also demonstrated that patients continued to take eslicarbazepine acetate with retention rates ranging from 68-79% at one year.

The median daily dose of eslicarbazepine throughout this one year treatment was 800mg.

Eslicarbazepine acetate is also novel in that it can be given as a true one tablet once a day regimen at its median daily dose as defined in clinical trials as 800mg.

Zebinix (eslicarbazepine acetate) offers patients improved seizure control with a favourable safety profile. Patients also report improvements in health-related quality of life measures such as ‘seizure worry’ and ‘cognitive function’ as well as improvement in the MADRS (Montgomery-Asberg Depression Rating Scale) depressive symptoms scale. Depression is often reported by patients with poorly controlled epilepsy.

The EU approval of eslicarbazepine acetate (Zebinix)was based on data from phase II and three phase III, double-blind, randomised, placebo-controlled, multi-centre trials involving 1,049 patients from 23 countries. Patients had a history of at least four partial seizures per month despite treatment with up to three concomitant anti-epileptic drugs.

“The effective treatment of patients with partial-onset seizures remains a major challenge for clinicians as well as for patients with epilepsy and their families,” stated Nick Burgin, managing director Eisai in UK.

Epilepsy affects approximately 1 in 100 people, and is one of the most common neurological diseases. Successful treatment of partial-onset seizures (the most common type of epilepsy) remains a challenge. Up to 40% of patients with partial seizures do not achieve seizure control with current anti-epileptics.

Epilepsy is a chronic neurological disease characterised by abnormal discharges of neuronal activity causing seizures. Clinically, these manifest as convulsions or jerking of muscles. Depending on the seizure type, seizures may be limited to one part of the body, or may be generalised to involve the whole body. 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 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.

Furthermore, adverse events, such as lightheadedness (dizziness), somnolence (sleepiness), and cognitive slowing, are highly prevalent with existing anti-epileptic agents. Hence, there is a need for new anti-epileptic agents that offer effective reduction in seizure frequency combined with a favourable safety profile.

Headquartered in London,Eisai Europe Limited is a European subsidiary of Eisai Co., Ltd.  Tokyo. Eisai announced in February this year that it had entered into a license and co-promotion agreement with Bial – Portela & C(a), S.A. which gave Eisai Europe Limited. rights to sell Bial’s anti-epileptic drug Zebinix (eslicarbazepine acetate) in Europe.

Eisai is one of the world’s leading R&D-based pharmaceutical companies. Eisai concentrates its R&D activities in three key areas: Integrative Neuroscience: Alzheimer’s disease, multiple sclerosis, neuropathic pain, epilepsy, depression, etc; Integrative Oncology: Anticancer therapies; tumour regression, tumour suppression, antibodies, etc and Supportive cancer therapies; pain relief, nausea, etc and Vascular/Immunological Reaction: 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.