Hatfield, England (ots/PRNewswire) - PRESS RELEASE FOR EU MEDIA ONLY: NOT FOR SWISS/U.S JOURNALISTS
Primary endpoint met for Fycompa(R)(perampanel) as adjunctive therapy for
refractory generalised tonic-clonic seizures
Phase III data announced today demonstrate control of primary generalised tonic-clonic seizures (PGTC) with adjunctive Fycompa(R) (perampanel), Eisai's first-in-class epilepsy.[1] Perampanel is indicated for the adjunctive treatment of partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.[2]
Study 332 is a double-blind, randomised, placebo-controlled, multicentre, parallel-group trial to evaluate the efficacy and safety of adjunctive perampanel for refractory PGTC seizures. 164 people (>12 years old) with PGTC seizures, despite treatment with one to three concomitant anti-epileptic drugs (AEDs), were randomised to receive perampanel or placebo in a 1:1 ratio. Results demonstrate that perampanel significantly reduces PGTC seizure frequency and improved responder rates (greater than or equal to50% reduction in seizure frequency per 28 days in the maintenance period, relative to baseline), the study's two primary outcome measures, when compared to placebo.[1]
The most frequently observed adverse events (10% in the perampanel arm and greater than placebo) were dizziness, fatigue and headache, irritability and somnolence. The adverse event profile observed in this study was similar to that observed in other Fycompa studies.[1]
"Tonic-clonic seizures can have serious consequences for patients and new effective treatment options are always needed. We are pleased that study 332 has reported positive outcomes," commented Dr Makarand Bagul, Director, Neurology EMEA Eisai Medical Strategy Lead .
Based on these results, Eisai plans to submit an application to the European Commission in 2014 for an indication expansion for perampanel to include the adjunctive treatment of PGTC seizures in people with epilepsy.
Perampanel is the only licensed AED to selectively target AMPA receptors, a protein in the brain which plays a critical role in the spread of seizures.[3] This mechanism of action is different to all other, currently available AEDs. In addition, perampanel has the added benefit of convenient, once-daily dosing at bedtime[2] and, significantly, is the only new-generation partial epilepsy treatment approved to treat adolescents (>12 years) with epilepsy from launch.
Discovered and developed by Eisai in Europe and Japan, perampanel is manufactured in the UK and was approved by the European Commission on 23 July 2012. Fycompa is now approved in more than 35 countries worldwide.
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Phase III Study Shows Eisai's First-In-Class Treatment Fycompa (Perampanel) Significantly Reduces Primary Generalised ...