Fycompa is a highly selective, noncompetitive AMPA receptor antagonist discovered and developed by Eisai. With epileptic seizures being primarily mediated by the neurotransmitter glutamate, the agent works as a first-in-class AED that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors. It is approved in more than 40 countries worldwide, mostly in Europe and North America, and has been already launched in over 15 countries around the world including the United States and a number of European countries.
Over half of the 50 million people with epilepsy worldwide are estimated to live in Asia1. As approximately some 60% of patients diagnosed with epilepsy have partial seizures, of which approximately 25% to 30% are unable to control their seizures with current treatment options, this is a disease with significant unmet medical needs. Fycompa, which has a mechanism of action different to that of other licensed AEDs, offers a new treatment option for epilepsy patients with partial-onset seizures. Indicated for a wide range of patients, including adults and adolescents aged 12 years and older, the agent has the added benefit of once-daily oral dosing, which is expected to reduce the potential pill-burden a patient with epilepsy may experience as well as improve patient drug compliance.
Eisai considers epilepsy as a therapeutic area of focus and in addition to Fycompa, holds an extensive epilepsy product portfolio. By providing multiple treatment options in Asia, including Hong Kong, Eisai seeks to make continued contributions to addressing the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.
1. About Epilepsy
Epilepsy is a medical condition that produces seizures, affecting a variety of mental and physical functions. A patient is considered to have epilepsy after two or more unprovoked seizures. A seizure occurs when a brief, strong surge of electrical activity affects part or all of the brain. An individual can have various symptoms, from convulsions and loss of consciousness, to some that are not always recognized as seizures, such as blank staring, lip smacking, or jerking movements of arms and/or legs.
Epilepsy can develop at any age and 0.5% to 2% of people will develop epilepsy during their lifetime. Epilepsy reportedly affects nearly 1 million people in Japan, 2.4 million people in Europe (G5), 2.2 million people in the United States, and more than 50 million people worldwide. Epilepsy constitutes an area in which there are still significant unmet medical needs, with partial-onset epilepsy accounting for approximately 55% of all epilepsy cases in Hong Kong, and from 20% to 40% of patients living with partial epilepsy in that country not achieving seizure freedom despite therapy with antiepileptic drugs (AEDs).
2. About Fycompa (Perampanel)
Fycompa, a novel chemical entity discovered and developed by Eisai, is a noncompetitive AMPA-type glutamate receptor antagonist. Fycompa is an antiepileptic drug that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors. The agent is currently approved in more than 40 countries and territories, including Europe and the United States, as an adjunctive treatment (once-daily oral dose) of partial-onset seizures and is also being evaluated in a Phase III study (Study 335) in Asia, including Japan. A Phase III study (Study 332) of the agent as an adjunctive therapy for the treatment of primary generalized tonic-clonic seizures (PGTC) conducted in the United States, Europe and Asia, including Japan, met its primary endpoint, and the regulatory applications for an indication expansion of the agent are under review in the United States and Europe. The company plans to submit a regulatory application covering both study 332 and study 335 in Japan in fiscal 2015. Furthermore, Eisai is conducting Phase II studies in Europe and the United States for partial-onset epilepsy in pediatric patients.
3. About the Phase III Studies
The clinical development plan for perampanel consisted of three global Phase III studies (Studies 306, 305 and 304) in which a total of 1,480 patients with epilepsy aged 12 years and older participated. The key goal of Study 306 was to identify the minimal effective dose and included four treatment arms (placebo, 2 mg, 4 mg, and 8 mg). Studies 304 and 305 included three arms (placebo, 8 mg, and 12 mg) and were to evaluate a more extended dose range.
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Eisai Launches Antiepileptic Drug Fycompa in Hong Kong