Key Data Highlight Positive Results for Fycompa® (Perampanel) at the American Epilepsy Society Annual Meeting 2015
HATFIELD, England, November 23, 2015 /PRNewswire/ --
PRESS RELEASE FOR EU MEDIA ONLY: NOT FOR SWISS/AUSTRIAN/US JOURNALISTS
Key data at the American Epilepsy Society (AES) 69th Annual Meeting in Philadelphia, 4-8 December, will show results from 15 posters on the safety, efficacy, and long-term effects of adjunctive Fycompa® (perampanel) in patients with epilepsy.
"These new data at AES 2015 reinforce Eisai's investment in epilepsy treatment options with the potential to improve outcomes in different patient populations. Epilepsy is a challenging condition to manage, it is therefore important that we strive to find effective treatments to support people with epilepsy," comments Neil West, Vice President, Global Neurology Business Unit, Eisai EMEA.
The continued development of its epilepsy portfolio 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. Eisai is committed to the therapeutic area of epilepsy and to address the unmet medical needs of people with epilepsy and their families.
The following abstracts are accepted for presentation at the AES annual meeting:
Abstract Number Abstract details
Abstract number: Effect of Adjunctive Perampanel in Pediatric Subjects
#1.184 With Epilepsy: Preliminary Safety and Efficacy Results
Saturday 5 December From Study 232
12:00-14:00
Hall A, Level 200 Ronald Davis, Jose A. Ferreira, Dinesh Kumar, Haichen
Yang, Antonio Laurenza,Sharon Dispoto
This analysis reports preliminary safety and efficacy
findings from an open-label Phase II pilot study of
perampanel oral suspension in pediatric subjects aged 2
to <12 years old with epilepsy.
Abstract number: Pharmacokinetics of Perampanel in Children with Epilepsy
#1.187 Aged 2-<12 Years
Saturday 5 December
12:00-14:00 Ben Renfroe, Yuko Umetsu, Mark Mintz, Sharon Dispoto, Jim
Hall A, Level 200 Ferry, Bhaskar Rege, Haichen Yang, Antonio Laurenza, Ziad
Hussein
This analysis reports the pharmacokinetics of perampanel
as adjunctive therapy in children compared to adolescents.
Abstract number: Efficacy of Perampanel by Baseline Seizure Frequency in
#1.188 Patients with Partial Seizures (Phase III Double-Blind
Saturday 5 December Studies)
12:00-14:00
Hall A, Level 200 Ben Renfroe, Yuko Umetsu, Mark Mintz, Sharon Dispoto, Jim
Ferry, Bhaskar Rege, Haichen Yang, Antonio Laurenza, Ziad
Hussein
This analysis evaluates the efficacy of perampanel in
subjects with drug-resistant partial seizures based on
their seizure frequency at the time of enrollment in
three Phase III perampanel double-blind studies.
Abstract number: Suicidality Events in Patients With Primary Generalized
#1.189 Tonic-Clonic Seizures (PGTCS): A Review of Study 332
Saturday 5 December
12:00-14:00 Alan B Ettinger, Ben Renfroe, Cindy Dobrinsky, Haichen
Hall A, Level 200 Yang, Antonio Laurenza, Betsy Williams,Anna Patten,
Francesco Bibbiani
This analysis of a randomized double-blind,
placebo-controlled study of subjects 12 years of age or
older with uncontrolled PGTCS reviews suicidal behavior
and ideation using adverse event reporting and the
Columbia Suicide Severity Rating Scale (C-SSRS).
Abstract number: Psychiatric and Behavioral Events with Perampanel in
#1.190 Patients with Primary Generalized Tonic-Clonic Seizures
Saturday 5 December (PGTCS): Study 332
12:00-14:00
Hall A, Level 200 Cindy Dobrinsky, Alan B Ettinger, William Rosenfeld,
Betsy Williams, Antonio Laurenza, Haichen Yang, Anna
Patten, Francesco Bibbiani
This analysis of a randomized double-blind,
placebo-controlled study of subjects 12 years of age or
older with uncontrolled PGTCS reviews psychiatric and
behavioral events using adverse event reporting to
further understand perampanel and psychiatric and
behavioral events.
Abstract number: Subanalysis by Baseline Antiepileptic Drugs (AEDs):
#1.191 Results From Perampanel Study 332 in Patients With
Saturday 5 December Primary Generalized Tonic-Clonic Seizures (PGTCS)
12:00-14:00
Hall A, Level 200 Batool Kirmani, Antonio Laurenza, Haichen Yang, Betsy
Williams, Anna Patten, Francesco Bibbiani
This sub-analysis evaluates the efficacy and safety of
perampanel by baseline antiepileptic drugs in subjects 12
years of age or older with uncontrolled PGTCS and taking
1-3 concomitant antiepileptic drugs.
Abstract number: Review of Pregnancy Events in Perampanel Clinical Studies
#1.192
Saturday 5 December Blanca Vazquez, Cindy Dobrinsky, Haichen Yang, Betsy
12:00-14:00 Williams, Dinesh Kumar, Antonio Laurenza, Cynthia Harden
Hall A, Level 200
This review compiles pregnancy data from perampanel
clinical studies.
Abstract number: Effect of Duration of Epilepsy on Adjunctive Perampanel
#1.193 Treatment in Patients With Drug-Resistant Partial
Saturday 5 December Seizures
12:00-14:00
Hall A, Level 200 Jonathan Halford, Haichen Yang, Betsy Williams,Tony Ma,
Antonio Laurenza
This analysis reports efficacy results of perampanel
adjunctive therapy in subjects with drug-resistant
partial seizures stratified by duration of epilepsy.
Abstract number: Analysis of Falls in the Phase III Perampanel Study of
#1.194 Primary Generalized Tonic-Clonic Seizures (PGTCS)
Saturday 5 December
12:00-14:00 Ilo E Leppik, Betsy Williams, Tony Ma,Anna Patten,Antonio
Hall A, Level 200 Laurenza, Francesco Bibbiani
This analysis is a systematic review of reported falls
evaluated to establish whether the fall was related to a
seizure.
Abstract number: Clinical Laboratory Evaluation and TEAEs Related to
#1.195 Cardiac, Hepatic and Renal Disorders: Perampanel PGTC
Saturday 5 December Phase III Study
12:00-14:00
Hall A, Level 200 W. Alvin McElveen, David G. Vossler, Betsy Williams,
Antonio Laurenza, Anna Patten, Francesco Bibbiani
This analysis evaluated laboratory tests and
treatment-emergent adverse events related to these tests,
as well as cardiac-, hepatic- and renal-related
treatment-emergent adverse events, in subjects aged 12
years or older enrolled in a primary generalized
tonic-clonic seizure Phase III study.
Abstract number: Long-Term Perampanel Treatment in Patients With
#1.196 Drug-Resistant Partial Seizures: greater than or equal
Saturday 5 December to 75% Responders and Seizure-Free Status
12:00-14:00
Hall A, Level 200 Haichen Yang, Gregory Krauss, Betsy Williams, Tony
Ma, Antonio Laurenza
This analysis reports on subjects with drug-resistant
partial seizures who have experienced a 75% reduction in
seizures or seizure freedom with long-term perampanel
therapy.
Abstract number: Efficacy and tolerability of perampanel in patients (pts)
#2.250 with secondarily generalized (SG) or primary generalized
Sunday 6 December tonic-clonic seizures (PGTC): a pooled analysis of four
12:00-14:00 randomized, Phase III studies
Hall A, Level 200
Terence O'Brien, Anna Patten, Francesco Bibbiani, Haichen
Yang, Betsy Williams, Antonio Laurenza
This post-hoc analysis evaluated efficacy and
tolerability of perampanel across all four Phase III
studies in patients with secondarily generalized or
primary generalized tonic-clonic seizures.
Abstract number: Efficacy and safety of adjunctive perampanel (PER) in
#2.263 adolescents with inadequately controlled partial-onset
Sunday 6 December seizures (POS): randomized, double-blind and open-label
12:00-14:00 extension (OLE) study
Hall A, Level 200
Vicente Villanueva, Ben Renfroe, Haichen Yang, Betsy
Williams, Dinesh Kumar, Antonio Laurenza
This is an analysis of long-term efficacy and
tolerability of adjunctive perampanel from the blinded
and open-label extension phases of Study 235, a
randomized, double-blind, placebo-controlled Phase II
study of adjunctive perampanel in adolescent patients
with inadequately controlled partial-onset seizures.
Abstract number: Long-term cognitive effects of adjunctive perampanel
#3.260 (PER) in adolescents for treatment of partial-onset
Monday 7 December seizures (POS): randomized, double-blind and open-label
12:00-14:00 extension (OLE) study
Hall A, Level 200
Randi Fain, Kimford J Meador, Lieven Lagae, Haichen Yang,
Betsy Williams, Dinesh Kumar, Antonio Laurenza
This analysis is an examination of the long-term
cognitive effects of adjunctive perampanel, based on the
blinded and open-label extension phases of Study 235.
Abstract number: Effect of adjunctive perampanel on growth and development
#3.262 in adolescents with inadequately controlled partial-onset
Monday 7 December seizures (POS): randomized, double-blind and open-label
12:00-14:00 extension (OLE) study
Hall A, Level 200
Dinesh Kumar, Lieven Lagae, J Eric Pina Garza, Haichen
Yang, Betsy Williams, Antonio Laurenza
This is an analysis of the long-term effects of
perampanel on growth and development of adolescent
patients from the blinded and open-label extension phases
of Study 235.
Notes to Editors
About Fycompa® (perampanel)
Perampanel is a highly selective, non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid)-type glutamate receptor antagonist. 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. Perampanel is indicated for the adjunctive treatment for partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older and for adjunctive treatment of primary generalised tonic-clonic seizures, in patients with idiopathic generalised epilepsy.
Since launch, perampanel has helped treat 33,496 people living with epilepsy across Europe.[1]
About Epilepsy
Epilepsy is one of the most common neurological conditions in the world, affecting approximately 6 million 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 which causes 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.
For the majority of idiopathic generalised epilepsy patients, a primary generalised tonic-clonic (PGTC) seizure begins with or without an aura, which is followed by rigid muscle. This leads to violent muscle contraction (clonic phase) and a loss of consciousness. As this is a serious event, it is seen as a major hindrance on daily life. While the seizure generally only lasts a few minutes, the patient will often feel confused or drowsy for a short period of time before returning to normal.[4],[5] PGTC seizures can also result in risk of injury and sudden unexplained death in epilepsy (SUDEP).[6]
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:
- Fycompa® (perampanel) Perampanel is indicated for use as a once-daily, adjunctive therapy for both primary generalised tonic-clonic seizures with idiopathic generalised epilepsy and for adjunctive treatment of partial onset seizures, with or without secondary generalised seizures, in patients with epilepsy aged 12 years or older
- Inovelon® (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients >4 years. (Rufinamide was originally developed by Novartis)
- Zonegran® (zonisamide) as monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy and as adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents and children aged six years and above. (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)
About Eisai Co., Ltd.
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 over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realise our hhc philosophy by delivering innovative products in multiple therapeutic areas with high-unmet medical needs, including Oncology and Neurology.
As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.
For more information about Eisai Co., Ltd., please visit http://www.eisai.com
References
1. Eisai Data on File, 2015
2. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf (Accessed November 2015)
3. Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007:48(12):2224-33
4. Epilepsy Foundation. Types of seizures. Available at: http://www.epilepsy.com/learn/types-seizures. (Accessed November 2015)
5. Epilepsy Foundation. IGE Summary. Available at: http://www.epilepsy.com/information/professionals/about-epilepsy-seizures/idiopathic-generalized-epilepies. (Accessed November 2015)
6. Smithson WH et al, Curr Neurol Neurosci Rep 2014 Dec; 14(12):502
Date of preparation: November 2015
Job code: Fycompa-UK0242
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