As Adjunctive Therapy for Partial-Onset and Generalized Tonic-Clonic Seizures
TOKYO, Mar 29, 2016 - (ACN Newswire) - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that its in-house-discovered antiepileptic drug (AED) Fycompa (perampanel hydrate) has been approved in Japan as an adjunctive therapy for partial-onset seizures (including secondarily generalized seizures) or primary generalized tonic-clonic seizures in patients with epilepsy showing inadequate response to other AEDs.
The approval was based on the results of a Phase III clinical study (Study 335)(1) of Fycompa administered as an adjunctive therapy in patients aged 12 years and older with refractory partial-onset seizures conducted in Japan and Asia, as well as the results of a global Phase III clinical study (Study 332)(2) of Fycompa administered as an adjunctive therapy in patients aged 12 years and older with primary generalized tonic-clonic (PGTC) seizures. In Study 335, Fycompa demonstrated a statistically significant reduction in the primary endpoint of seizure frequency at doses of 8 mg/day and 12 mg/day, compared to placebo. In Study 332, Fycompa demonstrated a statistically significant reduction in the primary endpoint of PGTC seizure frequency compared to placebo, and 30.9% of patients treated with Fycompa were free of PGTC seizures during the 13 week maintenance period (12.3% for placebo). The most common adverse events (>/=10% in the perampanel arms and greater than placebo) observed in Studies 332 and 335 were dizziness, fatigue, headache, somnolence and irritability.
Discovered at Eisai's Tsukuba Research Laboratories and developed in-house, Fycompa is a first-in-class AED, available in tablet form as a once-daily oral dose. It is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors. Fycompa is currently approved in more than 45 countries and territories, including Europe and the United States, 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. Fycompa has been also been approved in more than 35 countries, including Europe and the United States, for the adjunctive therapy of PGTC seizures in patients with epilepsy 12 years of age and older.
Epilepsy affects approximately 1 million people in Japan. As approximately 30% of patients with epilepsy are unable to control their seizures with currently available AEDs(3) this is a disease with significant unmet medical needs. Generalized tonic-clonic seizures are one of the most severe forms of epileptic seizures as they can cause significant injury to patients from falling down suddenly, and the frequency of these seizures is the most important risk factor associated with sudden unexpected death in epilepsy (SUDEP).(4)
Eisai considers neurology a therapeutic area of focus, and by providing Fycompa as a new treatment option in Japan in addition to the AEDs Inovelon and Fostoin as part of an extensive epilepsy product portfolio, Eisai 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.
(1) Product name Fycompa Tablets 2 mg, Fycompa Tablets 4 mg (2) Generic name Perampanel hydrate (3) Indication for use Adjunctive therapy for the types of seizures below in patients with epilepsy showing inadequate response to other AEDs Partial-onset seizures (including secondarily generalized seizures) Primary generalized tonic-clonic seizures (4) Dosage and administration The usual dose for adults and children 12 years of age or older is initially 2 mg once daily as perampanel at bedtime, and the daily dose may then be increased by 2 mg at intervals of 1 week or longer. The maintenance dose is 8 mg once daily in the absence of concomitant AEDs that accelerate the metabolism of this product, or 8-12 mg once daily in the presence of such concomitant drugs. Dosage may be increased or decreased as necessary by 2 mg at intervals of 1 week or longer depending on symptoms, but the maximum daily dose should not be over 12 mg.
About Eisai
Eisai Co., Ltd. (TSE:4523; ADR:ESALY) is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: integrative neuroscience, including neurology and psychiatric medicines; integrative oncology, which encompasses oncotherapy and supportive-care treatments; and vascular/immunological reaction. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. For more information about Eisai Co., Ltd., please visit www.eisai.com.
Source: Eisai
Contact:
Public Relations Department, Eisai Co., Ltd. +81-3-3817-5120
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