Eisai Presents New Data Analyses on Fycompa® (Perampanel) at American Epilepsy Society Annual Meeting PR Newswire HATFIELD, England, December 6, 2013 HATFIELD, England, December 6, 2013 /PRNewswire/ -- Eisai today announced that 16 abstracts highlighting new data analyses on Fycompa ^® (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. ^ "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. ^ ^, ^ 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 Eisai is committed to developing and delivering highly beneficial new treatments to help improve the lives of people with epilepsy. The development of AEDs is a major strategic area for Eisai in Europe, the Middle East, Africa, Russia and Oceania (EMEA). In the EMEA region, Eisai currently has four marketed treatments including: *Zonegran ^® (zonisamide) as monotherapy and adjunctive therapy in adults, adolescents and children above the age of 6 with partial-onset seizures, with or without secondary generalisation. (Zonegran is under license from the originator Dainippon Sumitomo Pharma) *Zebinix ^® (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. (Zebinix is under license from BIAL) *Inovelon ^® (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients >4 years. (Rufinamide was originally developed by Novartis) *Fycompa ^® (perampanel) for use as an adjunctive treatment for partial-onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older About Eisai Eisai is one of the world's leading research and development (R&D) based pharmaceutical companies and 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 human health care ( hhc ). Eisai concentrates its R&D activities in three key areas: *Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight loss *Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc. *Vascular/Immunological reaction including: thrombocytopenia, rheumatoid arthritis, psoriasis, inflammatory bowel disease With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 10,000 people worldwide. From its EMEA Knowledge Centre in Hatfield, UK, Eisai has recently expanded its business operations to include Europe, the Middle East, Africa, Russia and Oceania (EMEA). Eisai EMEA has sales and marketing operations in over 20 markets, including the United Kingdom, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Norway, Portugal, Russia, Slovakia, Spain, Switzerland, Sweden, the Netherlands and the Middle East. For further information please visit our web site http://www.eisai.co.uk References 1. Fycompa. Summary of Product Characteristics (updated November 2012) http://www.medicines.org.uk/emc/medicine/26951/SPC/Fycompa+2mg%2c4mg%2c6mg%2c8mg%2c10mg%2c12mg+film-coated+tablets/ [ http://www.medicines.org.uk/emc/medicine/26951/SPC/Fycompa+2mg%2c4mg%2c6mg%2c8mg%2c10mg%2c12mg+film-coated+tablets ] 2. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [ http://www.ibe-epilepsy.org/downloads/EURO Report 160510.pdf ] [Accessed 18 July 2012]. 3. Pugliatti M, et al. Epilepsia 2007: 48(12) 2224–2233. Date of preparation:December 2013 Job code: perampanel-UK2145 Contact: Media Enquiries: Eisai Europe Ltd, Cressida Robson / Charlotte Andrews, +44(0)7908-314-155 / +44(0)7947-231-513, Cressida_Robson@eisai.net, Charlotte_Andrews@eisai.net. 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Eisai Presents New Data Analyses on Fycompa® (Perampanel) at American Epilepsy Society Annual Meeting
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