EISAI TO PRESENT LATEST DATA ON FYCOMPA

Eisai Co., Ltd announced that the latest data on its in-house developed AMPA receptor antagonist Fycompa® (perampanel hydrate, “perampanel”) will be presented at the 69th American Epilepsy Society (AES) Annual Meeting to be held from December 4 to 8 in Philadelphia in the United States.

For this year's AES meeting, poster presentations will be given on 22 abstracts with highlights including additional and pooled analyses on the results of global Phase III clinical studies on primary generalized tonic-clonic (PGTC) seizures in patients with generalized epilepsy (Study 332) and on partial-onset epilepsy (Study 304, Study 305, Study 306), as well as the results of a Phase III clinical study on partial-onset epilepsy conducted in Asia including Japan. Furthermore, the overall results of Study 332, Study 304 and Study 306 were published in the major scientific journal Neurology, while the overall results of Study 305 were published in the specialist epilepsy journal Epilepsia.

Perampanel is a first-in-class antiepileptic drug (AED) discovered and developed by Eisai. With epileptic seizures being primarily mediated by the neurotransmitter glutamate, the agent is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors.

Results of PHASE III TRIAL OF ANTIEPILEPTIC DRUG PERAMPANEL

Eisai Co., Ltd announced today that an oral presentation highlighting results from a Phase III clinical study (Study 335) of its in-house developed antiepileptic drug (AED) perampanel hydrate (global product name: Fycompa®) in patients with refractory partial-onset seizures conducted in Asia, including Japan, was given at the 49th Congress of the Japan Epilepsy Society held from October 30 to 31 in Nagasaki, Japan. In the study, perampanel demonstrated a significantly higher reduction in seizure frequency compared to placebo.
In Japan, new drug applications were submitted in July 2015 seeking the approval of perampanel as an adjunctive therapy for partial-onset and generalized tonic-clonic seizures based on the results of Study 335 and other studies.
Study 335 was a Phase III clinical study conducted in Asia, including Japan, to evaluate the efficacy and safety of adjunctive perampanel therapy in 710 patients aged 12 years and older with refractory partial-onset seizures. In this study, eligible patients receiving one to a maximum of three AEDs were randomized to receive perampanel (4 mg, 8 mg or 12 mg) or placebo. 

In the study's primary endpoint of percent change in seizure frequency (per 28 days in the randomization phase relative to the pre-randomization phase), the percent change in the placebo group was -10.8% while in the perampanel (4 mg, 8 mg, 12 mg) groups it was -17.3%, -29.0% and -38.0%, respectively. The difference between perampanel and placebo was statistically significant for the perampanel 8 and 12 mg groups (p=0.0003 for 8 mg, p<0.0001 for 12 mg). 

Furthermore, in the study's secondary endpoint of percent change in seizure frequency of secondarily generalized seizures, the percent change in the placebo group was -12.1% while in the perampanel (4 mg, 8 mg, 12 mg) groups it was -17.9%, -45.0% and -52.5%, respectively, demonstrating that perampanel, depending on dosage, reduces seizure frequency in secondarily generalized seizures as well, especially the 12 mg group which showed over a 50% reduction in seizure frequency.

The most common adverse events (>10% in the perampanel groups) observed in the study were dizziness, somnolence and nasopharyngitis.