HATFIELD, England, April 18, 2012 /PRNewswire/ --
This press release is for European media only
Eisai today announces the publication of results from a pivotal Phase III study[1] of perampanel, an investigational, highly selective, non-competitive AMPA-type glutamate receptor antagonist developed as an adjunctive therapy for partial seizures in adult patients with epilepsy.
The Study 306 data, published today in Neurology(R), provides evidence that, as an adjunctive therapy, 4 and 8 mg/day doses of perampanel are effective and well-tolerated in reducing uncontrolled partial-onset seizures (with or without secondary generalisation) when compared with placebo.[1] Efficacy in seizure reduction was seen despite treatment with up to three other anti-epilepsy drugs (AEDs).[1] The results from Study 306 are one of three pivotal Phase III studies in the EXPLORE (EXamining Perampanel Observations from Research Experience) clinical trial programme.
Marketing authorisation applications for perampanel are currently under review with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
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 is currently developing perampanel for the potential adjunctive therapy of partial seizures in patients with epilepsy. 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.
Study 306, the first in the Phase III EXPLORE (Examining Perampanel Observations from Research Experience) trials, set out to evaluate the efficacy and safety of perampanel (2, 4, and 8 mg/day) added to 1-3 concomitant AEDs in patients with uncontrolled partial-onset seizures. 706 patients were randomised and received trial medication (623 completed the trial). The primary endpoint for the EMA is 50% responder rate and the FDA is median percent change in seizure frequency. During this double-blind, placebo-controlled trial, patients with persisting seizures on 1-3 AEDs were randomised to perampanel 2, 4, and 8 mg/day or placebo following a 6-week baseline phase. Perampanel was titrated weekly by 2 mg/day and maintained at the dose achieved for 13 weeks. Analysis of covariance was performed on all treated patients with any seizure data (recorded in daily diaries) in the double-blind phase.
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Neurology® Publishes Results From Pivotal Study of Eisai´s Investigational Epilepsy Treatment perampanel