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.
"The approval of Fycompa by Swissmedic is very good news for both doctors and patients as the new drug provides a valuable new option for the treatment of partial-onset epilepsy. Uncontrolled seizures can severely impact patient quality of life and this new treatment may potentially help people in Switzerland achieve better seizure control, " commented Dr Med Guenter Kraemer, Medical Director, Swiss Epilepsy Centre. "In addition, Fycompa has the added benefit of once daily dosing, which may optimise adherence in patients already taking other medicines."
An estimated 70,000 people live with epilepsy in Switzerland.[3] Epilepsy is one of the most common neurological conditions in the world.[4] The successful treatment of partial-onset seizures (the most common type of epilepsy) remains a challenge. Up to 30% of patients with partial-onset seizures do not achieve seizure freedom despite appropriate therapy with anti-epileptic drugs.[5]
Perampanels approval by 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 is currently available in the UK, Denmark, Germany, Sweden and Austria. The FDA approved Fycompa for use in the US on 22 October 2012.
Discovered and developed by Eisai in Europe and Japan, and is going to be manufactured in the UK. Perampanel is the first and only licensed AED in Europe with a mode of action that selectively targets AMPA receptors, which are thought to play a central role in seizure generation and spread.[9] This first in class treatment selectively targets the transmission of seizures by blocking the effects of glutamate, which can trigger and maintain seizures. In addition, perampanel has the added benefit of convenient, once-daily dosing taken at bedtime, [10] and it is the only contemporary epilepsy treatment approved for adolescents from launch which can lead to earlier seizure control in younger patients.
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 Treatment Fycompa® (Perampanel) Approved In Switzerland For Partial Epilepsy