ºÚÁÏÍø

ºÚÁÏÍø., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “ºÚÁÏÍø”) announced today that the latest data on its antiepileptic drugs (AED) perampanel (product name: Fycompa®) and rufinamide (product name: Inovelon®, U.S. product name: BANZEL®) will be presented at the 70th American Epilepsy Society (AES) Annual Meeting to be held from December 2 to 6 in Houston in the United States.

For this year's AES meeting, poster presentations will be given on eight abstracts for perampanel which include the results of Phase Ⅱ trials (Study 231, Study 233) of adjunctive perampanel in Japanese patients with refractory partial-onset seizures. Regarding rufinamide, a poster presentation will be given on the safety and cognitive development effects of adjunctive rufinamide in pediatric subjects with inadequately controlled Lennox-Gastaut Syndrome (LGS) from the final results of Study 303. Along with three poster presentations on health economics and outcome research, a total of 12 poster presentations will be given.

Perampanel is a first-in-class AED discovered and developed by ºÚÁÏÍø. With epileptic seizures being 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. The agent is currently approved in more than 50 countries and territories as an adjunctive treatment of partial-onset seizures (with or without secondarily generalized seizures) in adult and adolescent patients with epilepsy 12 years of age and older. In addition, perampanel is approved in more than 40 countries as an adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older.
Furthermore, ºÚÁÏÍø has submitted a supplemental application to the U.S. Food and Drug Administration for a partial label change for perampanel as monotherapy for treatment of partial-onset seizures in patients with epilepsy 12 years of age and older.

Rufinamide is believed to exert its antiepileptic effects by regulating activity of voltage-gated sodium channels in the brain involved in the overexcitement of neurons that potentially causes seizures, so as to prolong their inactive state. The agent is approved as an adjunctive therapy to other AEDs in the treatment of seizures associated with LGS in Europe and the United States. In Japan, the agent is approved as an adjunctive therapy to other AEDs in the treatment of tonic and atonic seizures associated with LGS when therapy with other AEDs is considered inadequate. Rufinamide is currently approved in more than 30 countries worldwide.

ºÚÁÏÍø considers epilepsy a therapeutic area of focus and by providing multiple treatment options in addition to perampanel and rufinamide as part of an extensive epilepsy product portfolio, ºÚÁÏÍø seeks to make continued contributions to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.