Perampanel is the first and only licensed anti-epileptic drug (AED) to selectively target AMPA receptors, a protein in the brain which plays a critical role in causing seizures.[2] This mechanism of action is different to 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 with epilepsy from launch.
"Effective seizure management still remains a challenge for up to 30% of people with partial onset seizure despite appropriate therapy. Perampanel offers a new mechanism of action that can potentially help people in Switzerland achieve better seizure control, " commented Dr Gunther Kramer, Medical Director, Swiss Epilepsy Centre. "Uncontrolled seizures can severely impact a patients quality of life and the new treatment will give an additional option to patients to help manage their condition. We welcome this new addition to doctors epilepsy treatment armamentarium."
Epilepsy is one of the most common neurological conditions in the world[3] and an estimated 70,000 people live with epilepsy in Switzerland.[4] The incidence of uncontrolled partial epilepsy remains high despite many new AEDs, and between 20 - 40% of people with newly diagnosed epilepsy will become refractory to treatment.[5]
Perampanels approval by the Swiss agency for the authorisation and supervision of therapeutic products, Swissmedic, was based on three global pivotal Phase III studies with 1,480 subjects. These randomised, double-blind, placebo-controlled and dose-escalated studies showed consistent results in the efficacyand tolerability of perampanel as an adjunctive therapy in people with partial-onset seizures (with or without secondary generalisations).[6], [7], [8] The most commonly reported adverse events were dizziness, somnolence, fatigue, headache, falls, irritability and ataxia.[6], [7], [8]
Perampanel was approved by the European Commission on 23 July 2012, and in Europe the drug is currently available in the UK, Denmark, Germany, Sweden, Norway and Austria. Swissmedic approved perampanel for use in December 2012 and the FDA approved perampanel for use in the US on 22 October 2012. Discovered and developed by Eisai in Europe and Japan, perampanel is going to be manufactured in the UK.
The development of perampanel underscores Eisais human health care (hhc) mission, the companys commitment to innovative solutions in disease prevention, cure and care for the health and well-being of people worldwide. Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of patients with epilepsy and their families. Eisai is proud to currently market more epilepsy products in Europe, the Middle East, Africa and Russia (EMEA) than any other company.
Notes to Editors
About Perampanel
Perampanel is licensed in Europe Union and Switzerland as an adjunctive treatment for people aged 12 years and older with partial-onset seizures, with or without secondarily generalised seizures.[1]
Perampanel is a highly selective, non-competitive AMPA ( alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid)-type glutamate receptor antagonist that has demonstrated seizure reduction in Phase II and III studies. AMPA receptors, widely present in almost all excitatory neurons, transmit signals stimulated by the excitatory neurotransmitter glutamate within the brain and are believed to play a role in central nervous system diseases characterised by excess neuroexcitatory signalling including epilepsy, neurodegenerative disorders, movement disorders, pain and psychiatric disorders.[1]
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New First-in-Class Epilepsy Treatment Fycompa® (Perampanel) Launches in Switzerland