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EMA considers two epilepsy treatments

The European Medicines Agency has accepted for review the marketing authorisation application for Eisai's perampanel while the agency's CHMP has recommended the approval of ViroPharma's Buccolam

The European Medicines Agency (EMA) has accepted for review the marketing authorisation application (MAA) for Eisai's perampanel as a treatment for partial-onset seizures in patients with epilepsy.

Perampanel is a first-in-class, highly selective non-competitive AMPA-type glutamate receptor antagonist.

The efficacy, safety and tolerability of perampanel was demonstrated by three phase III global, randomized, double-blind, placebo-controlled, dose-escalation studies in 1,480 epilepsy patients.

The primary and secondary endpoints were the same in all the studies: 50 per cent responder rate, standard median per cent seizure reduction, percentage reduction of complex partial plus secondarily generalised seizures and evaluation for dose response.

Perampanel also has the benefit of once daily dosing, helping to reduce the potential pill-burden a person with epilepsy may experience.

Professor Bernhard Steinhoff, medical director and executive chief physician of the epilepsy clinic for adults, Kork Epilepsy Centre, Germany, said: "Uncontrolled seizures have a severe impact on patient quality of life and everyday function, so we look forward to the possibility of being able to offer epilepsy patients a new treatment option in the near future."

Eisai has simultaneously submitted a new drug application to the US Food and Drug Administration (FDA) for perampanel.

Meanwhile the Committee for Medicinal Products for Human Use (CHMP) has also recommended the approval of ViroPharma's Buccolam (midazolam, oromucosal solution), for treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents, from three months to less than 18 years.

If approved by the European Commission, Buccolam would be the first product approved through the centralised Paediatric Use Marketing Authorisation (PUMA) procedure.

Buccolam is oral midazolam provided in a pre-measured, age-specific dose formulation for convenient buccal (via the cavity between the cheek and gum line) delivery. Buccal midazolam has been shown in four clinical studies to be either comparable or superior in both its effectiveness and speed of onset of action to the current standard treatment, rectally-administered diazepam, for terminating paediatric convulsive epileptic seizures.

28th June 2011

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