HATFIELD, England, October 4, 2012 /PRNewswire/ --
New results for Fycompa(R) (perampanel) presented today at leading epilepsy
conference
New data shared today with Europes epilepsy community at the 10th European Congress on Epileptology (ECE) in London, demonstrate the efficacy of once-daily Fycompa(R) (perampanel) in reducing partial-onset seizures, the most common form of epilepsy, and its effectiveness and flexibility of use as add-on therapy.
The successful treatment of partial-onset seizures (the most common form of epilepsy) remains a significant challenge in some patients and the incidence of uncontrolled partial epilepsy remains high, despite many existing anti-epileptic drugs (AEDs); between 20 - 40% of patients with epilepsy have remained poorly controlled despite these treatments.[1] The new data supports the use of perampanel as a new therapeutic option for this hard-to-treat patient population.
Results from two separate analyses of pooled data from the perampanel pivotal Phase III clinical trial programme endorse the efficacy and safety of the new AED at clinically relevant doses.[2] In addition, the results show that perampanel decreased the frequency of both complex partial seizures and secondarily generalised seizures.[3] In a third analysis of the pooled trial data, patients with uncontrolled partial-onset seizures taking any of the five most commonly-used AEDs with perampanel as an add-on therapy experienced a reduction in their seizure frequency. Patients generally received additional benefit from increased doses of perampanel.[4]
"This first-ever presentation of the pooled data from the perampanel Phase III trial programme has been anticipated by the epilepsy community. These results complement to the wealth of efficacy and safety data from the clinical development programme supporting the use of the new treatment. In addition, they further demonstrate the important adjunctive role that perampanel may have in the treatment of patients with partial onset seizures in Europe, " commented Professor Bernhard Steinhoff Medical Director and Executive at the Epilepsy Centre, Kehl-Kork, Germany.
Specific results from the three new analyses include:
Discovered and developed by Eisai in Europe and Japan, perampanel is the first and only licensed AED in Europe with a mode of action that selectively targets AMPA receptors, which are thought to play a central role in seizure generation and spread.[5] This first in class treatment selectively targets the transmission of seizures by blocking the effects of glutamate, which can trigger and maintain seizures. In addition, perampanel has the added benefit of convenient, once-daily dosing taken at bedtime, [6] and it is the only contemporary epilepsy treatment approved for adolescents from launch which can lead to earlier seizure control in younger patients.
The European Commissions (EC) Marketing Authorisation Approval of perampanel 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 patients with partial-onset seizures (with or without secondary generalisations).[7], [8], [9] The most commonly reported adverse events were dizziness, headache, somnolence, irritability, fatigue, falls, and ataxia.[7], [8], [9]
Excerpt from:
First Presentation of Pooled Phase III Data Supporting Europe´s Newest Partial Epilepsy Treatment