The Launch of Once-Daily Pill Gives New Hope for Epilepsy Patients
Japanese pharmaceutical giant Eisai has launched a new epilepsy drug in Europe following approval by the European Commission.
Discovered and developed in the United Kingdom, Fycompa® (perampanel) is an important new addition to the treatment of epilepsy in Europe as it has efficacy in difficult-to-treat patients with uncontrolled partial onset of seizures - the most common form of the disease. The new therapy is the first approved epilepsy treatment to selectively target AMPA receptors, a protein in the brain which plays a critical role in the spread of epileptic seizures, that are critical for the initiation and spread of seizures. It is different from current AEDs and the first and only licensed AED to exhibit clinical efficacy by blocking AMPA receptors. The AMPA receptor is widely present in almost all excitatory neurons. It is believed to play an important role in a large number of central nervous system diseases with similar neuropathology.
The new therapy has demonstrated efficacy in partial onset seizures with secondarily generalisations seizures, and is indicated as an add-on treatment for partial-onset seizures, with or without secondarily generalised seizures. The drug is the only new-generation partial epilepsy treatment approved to treat adolescents with epilepsy from launch. Perampanel has the added benefit of convenient, once-daily dosing at bedtime.
The worldwide supply of Perampanel will be manufactured, packaged and distributed from the company’s new £100 million facility in Hatfield, Hertfordshire.
Perampanel’s approval by the European Commission (EC) 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).The most commonly reported adverse events were dizziness, somnolence, fatigue, headache, falls, irritability and ataxia.
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