Publicado 06/12/2013 01:02
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Eisai Presents New Data Analyses on Fycompa® (Perampanel) at American Epilepsy Society Annual Meeting (1)

HATFIELD, England, December 6, 2013 /PRNewswire/ --

Eisai today announced that 16 abstracts highlighting new data analyses on Fycompa(R) (perampanel) will be presented at the 67th annual American Epilepsy Society (AES) meeting in Washington, D.C. between 6-10 December. Perampanel is indicated in the European Union (EU) for the adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.[1]

"These data analyses highlight Eisai's clinical research with Fycompa and reinforce our commitment to the epilepsy community," commented Lynn Kramer, MD, President of the Neuroscience and General Medicine Product Creation Unit and Chief Clinical Officer of Eisai Product Creation Systems, Eisai's research and development organisation.

The following abstracts regarding perampanel will be presented at this year's AES Meeting:

        
        Abstract Number Abstract Name
                        Assessment of Liver Toxicity in Perampanel-Treated
        1.140           Subjects: Pooled Results From Phase III Clinical Trials
        Poster Session  Antonio Laurenza, Haichen Yang, Betsy Williams, Sharon
        1               Zhou, Jim Ferry
                        Lack of Effect of Perampanel on QT Interval Duration:
                        Results From a Thorough QT Analysis and Pooled Phase III
                        Clinical Trials
        1.141
                        Haichen Yang, Antonio Laurenza, Betsy Williams, Anna
        Poster Session  Patten, Ziad Hussein, Jim Ferry
        1               Efficacy and Safety of Perampanel in the Subgroup of
                        Elderly Patients Included in the Phase III Epilepsy
        1.142           Clinical Trials
        Poster Session  Betsy Williams, Robert Wechsler, Antonio Laurenza, Haichen
        1               Yang, Sharon Zhou, Ilo Leppik
                        Pharmacokinetics of Perampanel: Results From Phase I
        1.143           Clinical Pharmacology Studies
        Poster Session  Barry E. Gidal, Antonio Laurenza, Haichen Yang, Betsy
        1               Williams, David A. Verbel, Jim Ferry
                        GABA vs. Non-GABA Mechanism of Action of Concomitant
                        Antiepileptic Drugs: Post-hoc Analysis of Pooled
        1.144           Perampanel Phase III Studies
        Poster Session  Mare Muller, Haichen Yang, Betsy Williams, Tony Ma,
        1               Antonio Laurenza, Steve Chung
                        Subgroup Analysis by Gender in Perampanel Phase III
        1.145           Studies of Patients Diagnosed With Partial-Onset Seizures
        Poster Session  Blanca Vazquez, Haichen Yang, Betsy Williams, Sharon Zhou,
        1               Antonio Laurenza
                        Review of Psychiatric and Behavioral Events in Perampanel
        1.146           Clinical Studies
        Poster Session  Alan B. Ettinger, Antonia LoPresti, Haichen Yang, Betsy
        1               Williams, Sharon Zhou, Randi Fain, Antonio Laurenza
                        Pooled Perampanel Phase III Trials: Time to Onset and
        1.147           Duration for Most Common Adverse Events
        Poster Session  David Ko, Haichen Yang, Betsy Williams, Dongyuan Xing,
        1               Antonio Laurenza
        1.154           Evaluation of Abuse Potential of Perampanel
        Poster Session  Jim Ferry, Haichen Yang, Betsy Williams, Kate Bradshaw,
        1               Reginald V. Fant, Antonio Laurenza
                        Efficacy and Safety of Adjunct Perampanel Based on Number
                        of Antiepileptic Drugs at Baseline and Baseline Predictors
        1.230           of Efficacy: Phase III Post-Hoc Analysis
        Poster Session  Tracy Glauser, Antonio Laurenza, Haichen Yang, Betsy
        1               Williams, Dongyuan Xing, Randi Fain
                        Lesional vs. Non-lesional Partial Epilepsy: Post-hoc
        2.048           Analysis of Pooled Perampanel Phase III Studies
        Poster Session  Stephanie Marsh, Haichen Yang, Betsy Williams, Steve
        2               Huang, Antonio Laurenza, Steve Chung
                        Efficacy and Safety of Perampanel in Patients With
                        Neurologic & Psychiatric Comorbidities: Post-hoc Analysis
        2.049           of Phase III Epilepsy Trials
        Poster Session  David Squillacote, Haichen Yang, Betsy Williams, Sharon
        2               Zhou, Antonio Laurenza, Victor Biton
                        Analysis of Aggression in Perampanel Phase III Epilepsy
        2.050           Clinical Trials
        Poster Session  Antonia LoPresti, Alan B. Ettinger, Haichen Yang, Betsy
        2               Williams, Sharon Zhou, Randi Fain, Antonio Laurenza
                        Effect of Ketoconazole on Perampanel Pharmacokinetics
        2.063
                        Rama Maganti, Antonio Laurenza, Haichen Yang, Betsy
        Poster Session  Williams, David A. Verbel, Edgar Schuck, Jim Ferry, Barry
        2               E. Gidal
                        Exploration of Adverse Events by Region, and Detailed
                        Focus on Psychiatric Events, With Long-term Open-label
                        Perampanel Treatment
        2.148
                        Elinor Ben-Menachem, Gregory Krauss,
        Poster Session
        2               Michelle Gee, Makarand Bagul, Dinesh Kumar
                        Long-term Retention, and Reasons for Discontinuations,
                        With Perampanel Treatment in Pharmacoresistant Focal
        3.211           Seizures
        Poster Session  Jerry Shih, Emilio Perucca, Michelle Gee, Makarand Bagul,
        3               Dinesh Kumar

The on-going research into perampanel underscores Eisai's human health care (hhc) mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and wellbeing of people worldwide.

Notes to Editors

About Perampanel

Perampanel is licensed in the European Union (EU) for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older.[1]

Perampanel is a highly selective, non-competitive AMPA ( alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid)-type glutamate receptor antagonist that has demonstrated seizure reduction in Phase II and III studies. AMPA receptors, widely present in almost all excitatory neurons, transmit signals stimulated by the excitatory neurotransmitter glutamate within the brain and are believed to play a role in central nervous system diseases characterised by excess neuroexcitatory signalling including epilepsy.[1]

Further information for healthcare professionals can be found at http://www.fycompa.eu

About Epilepsy

Epilepsy is one of the most common neurological conditions in the world, affecting approximately eight in 1,000 people in Europe, and an estimated 50 million people worldwide.[2],[3] Epilepsy is a chronic disorder of the brain that affects people of all ages. It is characterised by abnormal discharges of neuronal activity causing seizures. Seizures can vary in severity, from brief lapses of attention or jerking of muscles, to severe and prolonged convulsions. Depending on the seizure type, seizures may be limited to one part of the body, or may involve the whole body. Seizures can also vary in frequency from less than one per year, to several per day. Epilepsy has many possible causes but often the cause is unknown.

About Eisai EMEA in Epilepsy

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