New data presented by Eisai at the American Epilepsy Society (AES) annual meeting highlight efficacy and safety of perampanel to treat most severe form of epilepsy
Eisai presents new Phase III data at the American Epilepsy Society (AES) Annual Meeting in Seattle, Washington, of Fycompa (perampanel) as adjunctive therapy for primary generalised tonic-clonic seizures (PGTC). Perampanel is currently indicated for the adjunctive treatment of partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.[1]
Perampanel is the only licensed anti-epileptic drug (AED) to selectively target AMPA receptors, a protein in the brain which plays a critical role in the spread of seizures.[1] 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[1] and, significantly, is the only new-generation partial epilepsy treatment approved to treat adolescents (>12 years) with epilepsy from launch.
"This research has underlined the potential that perampanel has for people living with primary generalised tonic-clonic seizures. These data, together with the novel mechanism of action of perampanel and the convenience of a once-daily dose at bedtime, make it an important prospective treatment for people living with primary generalised tonic-clonic seizures," commented Professor Eugen Trinka, Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University, Salzburg, Austria.
The results from study 332 demonstrate that perampanel significantly reduces primary generalised tonic-clonic seizure frequency and improves responder rates (50% 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.[2] The study showed that adjunctive treatment with perampanel improved seizure control in people with idiopathic generalised epilepsy aged 12 years and over who were living with inadequately controlled primary generalised tonic-clonic seizures. 30.9% using perampanel were free of tonic-clonic seizures and it was well tolerated with a safety profile similar to refractory partial-onset seizures.
Epilepsy is one of the most common neurological conditions in the world. In Europe, at least six million people live with epilepsy, and 15 million Europeans will have one seizure at some time in their lives.[3] Currently, between 20-40% of patients with newly diagnosed epilepsy will become refractory to treatment.[4] Generalised tonic-clonic seizures are one of the most dangerous types of seizure.[5] The seizures start with a loss of consciousness and a sudden contraction of the muscles, which can cause the person to fall down (tonic phase). This is followed by violent convulsions (clonic phase) until the muscles finally relax.[6]
"These new data presented at AES will support the EU filing for perampanel as adjunctive therapy in the treatment of primary generalised tonic-clonic seizures," commented Dr Makarand Bagul, Director, Neurology EMEA Eisai Medical Strategy Lead.
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. Perampanel is now approved in more than 35 countries worldwide. Eisai submitted a Marketing Authorisation Application to the European Commission in August 2014 for an indication expansion for perampanel to include the adjunctive treatment of PGTC seizures in people with epilepsy.
The on-going clinical investigation of perampanel for different seizure types underscores Eisai's human health care (hhc) mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and wellbeing of people worldwide.
Notes to Editors
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New Data Show That 30% of People Were Free of Primary Generalised Tonic Clonic Seizures When Using Adjunctive Fycompa ...