HATFIELD, England, July 26, 2012 /PRNewswire/ --
Eisai today announces the publication of results from a pivotal Phase III study[1] of Fycompa(R) (perampanel), the first in a new class of adjunctive treatment in people with partial-onset seizures, with or without secondary generalised seizures, aged 12 years and older.
According to research published in the August 2012 issue of Neurology(R), the medical journal of the American Academy of Neurology, the Study 304 data, published online today show that once-daily, adjunctive perampanel at doses of 8 or 12mg improved seizure control in people with uncontrolled partial-onset seizures, and that both doses had an acceptable safety and tolerability profile. Study 304 is one of three pivotal Phase III studies in the EXPLORE (EXamining Perampanel Observations from Research Experience) clinical trial programme.
The successful treatment of partial-onset seizures (the most common type of epilepsy) remains a challenge in some people. The incidence of uncontrolled epilepsy remains high despite many new anti-epileptic drugs (AEDs) and it is estimated that the proportion of people diagnosed with epilepsy who, are or will become, refractory to treatment range from 20% to as high as 40%.[2]
Perampanel selectively (non-competitively) blocks postsynaptic AMPA receptor-mediated excitatory neurotransmission.[3,4] Epileptic seizures are primarily mediated by the neurotransmitter glutamate. As an AMPA receptor antagonist, perampanel selectively targets the transmission of seizures by blocking the effects of glutamate.[5,6] This mechanism of action, which is different to that of current AEDs, means that once approved perampanel will be the first approved AED in this new class of treatment.
In May 2012, the European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for the use of perampanel as an adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures, in people with epilepsy aged 12 years and older. EU approval of the new therapy is anticipated in Q3 of 2012. The drug is also currently under review with the US Food and Drug Administration (FDA).
The development of perampanel underscores Eisais human health care 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 and their families.
Notes to Editors
About perampanel
Eisai has developed perampanel for the adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older. 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. If approved, perampanel will be the first product in this class for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older.
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Pivotal Study of Eisai´s Partial Epilepsy Treatment Fycompa® (perampanel) Published in Neurology®