TOKYO, Apr 24, 2019 - (JCN Newswire) - Eisai Co., Ltd. has announced that the latest data on its dual orexin receptor antagonist lemborexant and its antiepileptic drug (AED) perampanel (product name: Fycompa) will be presented at the 2019 Annual American Academy of Neurology (AAN) Meeting to be held from May 4 to 10, 2019 in Philadelphia, Pennsylvania in the United States.
As major presentations, an oral presentation will be given on the next-morning residual effects of lemborexant from the results of three placebo-controlled, active comparator, randomized, double-blind clinical studies evaluating on-road driving performance as well as postural stability, and memory and attention performance directly after awakening.
Regarding perampanel, a total of 18 poster presentations will be given, including on the final analysis results from a Phase III clinical study (Study 311) in pediatric patients aged 4 to 12 years old with epilepsy, as well as on inpatient hospitalization risk in patients with epilepsy before and after perampanel treatment.
Eisai considers neurology a therapeutic area of focus, and strives to maximize the value of lemborexant and perampanel to further contribute to addressing the diverse needs of, as well as increasing the benefits provided to, patients and their families.
Lemborexant is a novel investigational small molecule compound, discovered and developed by Eisai in-house scientists, that inhibits orexin signaling by binding competitively to both orexin receptor subtypes (orexin receptor 1 and 2). In individuals with normal daily sleep-wake rhythms, orexin signaling is believed to promote periods of wakefulness. In individuals with sleep-wake disorders, it is possible that orexin signaling that regulates wakefulness is not functioning normally, suggesting that inhibiting inappropriate orexin signaling may enable initiation and maintenance of sleep. Additionally, a Phase 2 clinical study of lemborexant in patients with irregular sleep-wake rhythm disorder (ISWRD) and mild to moderate Alzheimer's dementia is underway.
About Perampanel (generic name, product name: Fycompa)
Perampanel is a first-in-class AED discovered and developed by Eisai. 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 AMPA receptors on postsynaptic membranes. Perampanel is available in tablet form to be taken once daily orally at bedtime. In addition, an oral suspension formulation has been approved in the United States.
Perampanel is currently approved in more than 55 countries and territories, including the United States, Japan, in Europe and in Asia as adjunctive treatment for partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 12 years of age and older. An application seeking approval for use in the adjunctive treatment of partial-onset seizures is under review in China, which has been designated for Priority Review. In addition, Perampanel has been approved in more than 50 countries, including the United States, Japan, in Europe and in Asia for treatment as an adjunctive therapy for tonic-clonic seizures in patients with generalized epilepsy 12 years of age and older. In the United States, Perampanel is approved for monotherapy and adjunctive use in the treatment of partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 4 years of age and older. In Japan, a supplementary new drug application has been filed seeking approval of Perampanel for use as monotherapy for partial-onset seizures, treatment for partial-onset seizures in pediatric patients aged 4 years and older, as well as a fine granule formulation. In Europe, an application has been submitted seeking the additional approval of Perampanel for adjunctive use in the treatment of partial-onset seizures (with or without secondarily generalized seizures) or primarily generalized tonic-clonic seizures in pediatric patients with epilepsy.
Furthermore, Eisai is conducting a global Phase III clinical study (Study 338) for the agent in patients with epileptic seizures associated with Lennox-Gastaut syndrome.
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including Neurology and Oncology.
Furthermore, we invest and participate in several partnership-based initiatives to improve access to medicines in developing and emerging countries.
For more information about Eisai Co., Ltd., please visit www.eisai.com
Public Relations Department Eisai Co., Ltd. +81-(0)3-3817-5120
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