Eisai starts two phase III studies for antiepileptic drug perampanel

Study 311 is a global multicenter, single-arm Phase III clinical study of perampanel in approximately 160 patients (ages 4 to less than 12 years) with inadequately controlled partial-onset seizures or primary generalized tonic-clonic seizures. However, in Japan, only patients with partial-onset seizures will be included.

The study will evaluate the safety, tolerability, and exposure-efficacy relationship of perampanel when administered as an adjunctive therapy.

Study 338 is a global multicenter, randomized, placebo-controlled, double-blind Phase III clinical study of perampanel in approximately 140 patients at least 2 years of age with inadequately controlled seizures associated with LGS. The study will evaluate whether perampanel, when given as adjunctive therapy, is superior to placebo.

Epilepsy affects approximately 1 million people in Japan, 2.9 million people in the United States, 6 million people in Europe, and approximately 60 million people worldwide. While epilepsy affects people of all ages, incidence is particularly high among children and the elderly.

As approximately 30% of patients with epilepsy are unable to control their seizures with currently available AEDs, this is a disease with significant unmet medical need.

LGS is one of the most severe and intractable forms of childhood-onset epilepsy. Characterized by multiple seizure types, the disorder is extremely difficult to control, with patients normally having to take several different AEDs. Seizures associated with LGS lead to falls due to sudden loss of consciousness.

LGS often causes delayed intellectual development and behavioral disturbances, and therefore has a significant impact on the quality of life of both patients and their families.

Perampanel is a first-in-class AED discovered at Eisai's Tsukuba Research Laboratories. It is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors.

Perampanel is available in tablet form to be taken once daily, and an oral suspension formulation has been approved in the United States and Europe. It is approved in countries around the world as an adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures, and primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.

In addition, Eisai has submitted a supplemental application 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 based on new U.S. Food and Drug Administration policy.

Together with the worldwide provision of Fycompa, Eisai is striving to continuously create new medicines for the field of epilepsy.

In addition, Eisai is promoting initiatives such as provision of the EMILY epilepsy support app with SOS and communication functionality in Japan to address the diverse needs of patients with epilepsy and their families around the world.