Results from a pooled analysis of three large Fycompa (perampanel) trials are published today in leading clinical and research epilepsy publication, Epilepsia.[1] These new data confirm the efficacy of perampanel as an adjunctive treatment for hard-to-treat partial seizures and also provides further reassurance that perampanel is well tolerated.
The publication groups together the three pivotal clinical studies for perampanel, Study 304, Study 306 and Study 307. The pooled analysis of these data from nearly 1,500 patients shows that perampanel reduced partial epilepsy seizure frequency and improved responder rates compared to placebo.[1] At randomised doses of 4-12 mg, perampanel conferred significant improvements in reducing seizure frequency and 50% responder rates for all partial seizures and complex partial (CP) seizures with secondary generalisation (SG seizures), compared with placebo. The analysis also showed that adjunctive perampanel was efficacious irrespective of the co-administered anti-epileptic drug (AED).[1]
Perampanel is the only licensed anti-epileptic drug in Europe that selectively targets AMPA receptors, which are thought to play a central role in seizure generation and spread.[2] 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.[3] Discovered and developed by Eisai in Europe and Japan, perampanel is the only 3rd generation epilepsy treatment approved for adolescents.
Perampanel is licensed as an adjunctive treatment for people aged 12 years and older with partial-onset seizures, with or without secondarily generalised seizures.[3] It was approved by the European Commission in July 2012 and the US FDA in October 2012. In Europe, it is currently available in the UK, Denmark, Germany, Sweden, Norway and Austria. Swissmedic, the Swiss Agency for Therapeutic Products, approved perampanel for use on 17 December 2012.
"These new data are consistent with the results seen in the individual trials and confirm the clinical value of perampanel in the treatment of partial seizures," noted Professor Bernhard Steinhoff from the Epilepsiezentrum Kork, Kehl-Kork, Germany. "Up to 40% of patients with epilepsy are, or become, refractory to treatment, potentially resulting in impaired quality of life and an increased risk of injury or unexpected sudden death. There is a real need for effective new AEDs with novel modes of action that can be given with the most commonly prescribed AEDs. Perampanel is therefore a very welcome new adjunctive therapy."
Patients with partial seizures despite receiving 1-3 AEDs, were randomised to once-daily placebo, perampanel 8 or 12 mg (studies 304[4], 305[5]), or placebo, perampanel 2, 4, or 8 mg (study 306[6]). Studies included a 6-week baseline period and double-blind treatment phase (6-week titration; 13-week maintenance). Primary endpoints were median change in partial seizure frequency (baseline vs. double-blind phase) and percentage of patients achieving greater than or equal to50% reduction in seizure frequency (baseline vs. maintenance). In the pooled analysis, these endpoints, as well as secondary, exploratory, and safety endpoints, were assessed.
The results of the pooled analysis showed that median reductions in partial seizure frequency were greater with perampanel 4 mg (-23.3%), 8 mg (-28.8%), and 12 mg (-27.2%) than placebo (-12.8%; p<0.01, each dose vs. placebo). Fifty percent responder rates were greater with perampanel 4 mg (28.5%), 8 mg (35.3%), and 12 mg (35.0%) than placebo (19.3%; p<0.05, each dose vs. placebo). Median reductions in complex partial seizure frequency were greater with perampanel 4 mg (-31.2%), 8 mg (-35.6%), and 12 mg (-28.6%) than placebo (-13.9%). Perampanel was generally well tolerated with most adverse events being mild or moderate.
The development of perampanel underscores Eisai's human health care mission, the company's 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. Eisai is proud to currently market more epilepsy products in Europe, the Middle East and Africa (EMEA) than any other company.
Notes to Editors
About Perampanel
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First-in-class Fycompa® (perampanel) Pooled Pivotal Phase III Data Published in Epilepsia