HATFIELD, England, Jan. 25, 2011 /PRNewswire/ – Eisai announced today that it will submit Marketing Authorization Applications in the United States and the European Union for the investigational compound perampanel (E2007) based on the results of three Phase III pivotal studies.
Perampanel is a first-in-class, highly selective non-competitive AMPA-type glutamate receptor antagonist, discovered and being developed by Eisai for adjunctive treatment of partial seizures in patients with epilepsy.
Partial seizures involve epileptic activity in just a part of the brain and the symptoms experienced depend on which area of the brain is affected.
The clinical development plan for perampanel consisted of three global Phase III studies: Studies 306, 305 and 304 in which a total of 1,490 patients participated.
The key goal of Study 306 was to identify the minimal effective dose and included four treatment arms (placebo, 2mg, 4mg, and 8mg).
Studies 304 and 305 included three arms (placebo, 8mg, and 12mg) and were to evaluate a more extended dose range.
The studies were similar in design: global, randomized, double-blind, placebo-controlled, dose-escalation, parallel-group studies.
The primary and secondary endpoints were the same in all the studies: standard median percent seizure reduction, 50% responder rate, percentage reduction of complex partial plus secondarily generalized seizures, and evaluation for dose response.
Each of the studies showed consistent results in the efficacy and tolerability of perampanel given as an adjunctive therapy in patients with partial seizures.
Based upon these study results, Eisai intends to submit regulatory applications simultaneously in the U.S. and EU during the first quarter of our Fiscal Year 2011.
The development of perampanel is an example of Eisai’s human health care corporate mission.
Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of patients with epilepsy and their families.