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Once daily anti-epileptic drug launches

Eisai announced the launch of Zebinix (eslicarbazepine acetate) in the UK on November 9
A novel, once daily anti-epileptic, Zebinix (eslicarbazepine acetate), has been launched in the UK  as adjunctive therapy in adults with partial-onset seizures, with or without secondary generalisation.
Developed from the current 'gold standard' treatment carbamazepine (launched in 1965), Zebinix (eslicarbazepine acetate) offers patients improved seizure control with a favourable safety profile. 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.

Patients using Zebinix (eslicarbazepine acetate) reported 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.

“Continued seizures bring significant risk of poor quality of life, reduced employment and the development of mental illness such as depression or anxiety. The launch of eslicarbazepine acetate should offer a new choice for patients and clinicians in reducing the burden of epilepsy," said Mike Kerr, professor of learning disabilities at Cardiff University, who has a special interest in the treatment and psychological impact of epilepsy.
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. 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 per cent at one year. The median daily dose throughout this one-year treatment was 800mg. Treatment-emergent adverse events, including dizziness, headache and somnolence, affected less than 10 per cent of patients in the pivotal studies.
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.

Epilepsy affects approximately 1 in 100 people – and the successful treatment of partial-onset seizures (the most common type of epilepsy) remains a challenge. Up to 40 per cent of patients with partial seizures do not achieve seizure control with current anti-epileptics.

9th November 2009


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