HATFIELD, England, September 9, 2015 /PRNewswire/ --
Further data shows Inovelon(R) (rufinamide) has favourable efficacy in Lennox-Gastaut
PRESS RELEASE FOR EU MEDIA ONLY: NOT FOR AUSTRIAN/SWISS/U.S. JOURNALISTS
Data at the International Epilepsy Congress in Istanbul show Fycompa(R) (perampanel) treatment may significantly reduce seizure frequency, both in patients with primary generalised tonic-clonic (PGTC) seizures (seizure frequency was reduced 62.3% versus 31.7% placebo shown in a subset analysis of a recently published phase 3 study (332) in patients having PGTC seizures with idiopathic generalised epilepsy), and partial epilepsy (8.6% of patients were seizure free at six months shown in a retrospective analysis of Spanish data of 315 patients with partial-onset seizures).,[ 2]
For patients with PGTC seizures, an up-titration of perampanel over 4 weeks may reduce the number of PGTC seizures experienced by 62.3% versus placebo (31.7%), and higher perampanel exposure was associated with a greater probability of response. The double-blind phase III study used pharmacodynamic modelling to describe and predict relationships between perampanel exposure and seizure outcomes in a typical male without concomitant enzyme-inducing anti-epileptic drugs.
In a second study examining patients with partial-onset seizures, data shows perampanel increases response and retention rates when used as an adjunctive treatment. In an interim update from a real-life study of 315 patients with partial onset seizures (POS) in Spain, at six months the retention rate was high at 79.4%, 8.6% of patients were seizure-free and 32.9% responded to treatment. Perampanel further reduced the frequency of secondary generalised seizures from 27.2% to 17.6%, and had significant effects in patients 65 or older and in patients that had tried five or more anti-epileptic drugs in this study.
"These results illustrate that perampanel's novel mechanism of action yields an excellent response in terms of seizure frequency, when used adjunctively with existing anti-seizure therapies, across the most common seizure types," comments Eugen Trinka, Chair of the Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University, Salzburg.
An independent group review eliminated 29.9% of patients, initially considered eligible, from inclusion in perampanel's recently published Study 332, to ensure appropriate classification of participants. This was the first PGTC seizure study to use external review.
Perampanel, an oral treatment with a simple titration regimen, is currently indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients from 12 years of age with epilepsy, and as adjunctive therapy for the treatment of primary generalised tonic-clonic seizures in patients aged 12 years and older with idioipathic generalised epilepsy. Perampanel is the only licensed anti-epileptic drug to selectively target AMPA receptors, a protein in the brain which plays a critical role in the spread of seizures. This mechanism of action is different to other, currently available anti-epileptic drugs.
A further sub-group analysis of another phase III trial, showed that Inovelon(R) (rufinamide) demonstrates favourable efficacy as adjunctive treatment for adults with Lennox-Gastaut syndrome. Median change from baseline in seizure frequency was -31.5% for rufinamide (n=21) versus +22.1% for placebo (n=10).
"Since Lennox-Gastaut syndrome often persists into adulthood, or may have late onset in adulthood, these data are promising and show that rufinamide is efficacious compared with placebo when used adjunctively", comments Pasquale Striano, University of Genoa, G. Gaslini Institute.
Rufinamide is currently indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in children four years and older. Lennox-Gastaut Syndrome is a severe, rare form of childhood-onset epilepsy, which affects nearly 208,000 people in Europe. Effective Lennox-Gastaut Syndrome management and compliance to treatment is of key importance to patients as the condition is characterised by a high number of seizures, people may experience up to 70 seizures a day. The condition often persists into adulthood and most people with this type of epilepsy will have developmental delay, mental retardation, and moderate to severe learning disabilities, in addition to, physiological and behavioural problems.,[ 11]
The development of perampanel and rufinamide demonstrates Eisai's commitment in the therapeutic area of epilepsy and further exemplifies the company's contribution to addressing the diversified needs of and increasing the benefits provided to patients and their families as shown by its human health care mission.
Notes to Editors
About Fycompa(R) (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.
About Inovelon(R) (rufinamide)
Rufinamide was approved for adjunctive therapy for Lennox-Gastaut Syndrome in Europe (under the brand name Inovelon) in 2007. Inovelon is available in 19 European countries as film-coated tablets containing 100mg, 200mg, and 400mg rufinamide. It is available in some countries as an oral suspension in orange flavour 40mg/ml concentration. The oral suspension formulation is bioequivalent to the tablet formulation on a milligram per milligram basis and in is available in Denmark, France, Germany, Portugal, Spain, and the United Kingdom.
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. It is a collection of syndromes that have many possible causes but often the cause is unknown. 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.
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. ,[ 15] PGTC seizures can also result in risk of injury and sudden unexplained death in epilepsy (SUDEP).
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(R) (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
- Inovelon(R) (rufinamide) for the adjunctive treatment of seizures associated with
Lennox-Gastaut Syndrome in patients >4 years. (Rufinamide was originally developed by
- Zonegran(R) (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(R) (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 [https://webmail.hhealth.com/owa/redir.aspx?C=6OjkkH_Oz0KcpqZqtz0gYu5W64yst9IIliR8UZVYwgaeouwuOzC4BDQV-nJBoz6bpw7MInczpyk.&URL=http%3a%2f%2fwww.eisai.com%2f ]
1. Krauss G et al. Abstract presented at IEC 2015.
2. Villanueva V et al. Abstract presented at IEC 2015.
3. French J.A et al. Abstracts presented at IEC 2015.
4. Fycompa, Summary of Product Characteristics. Available at: http://www.medicines.org.uk/emc/medicine/26951/ (Accessed August 2015)
5. Rogawski M et al. Revisiting AMPA receptors as an antiepileptic drug target. Epilepsy Currents 2011;11:56-63
6. Striano P, McMurray R. Abstracts presented at IEC 2015
7. Inovelon tablets Summary of Product Characteristics Available at: http://www.medicines.org.uk/emc/medicine/20165/SPC/ (Accessed May 2015)
8. Rare Diseases.Org. Available at: https://rarediseases.org/rare-diseases/lennox-gastaut-syndrome/ (Accessed August 2015)
9. Special Child. Disorder Zone Archives. Available at: http://www.specialchild.com/archives/dz-017.html (Accessed May 2015)
10. International Journal of Pharma and Bio Sciences. Available at: http://www.ijpbs.net/issue-3/82.pdf (Accessed May 2015)
11. MedScape references Lennox-Gastaut Syndrome. Available at: http://emedicine.medscape.com/article/1176735-overview (Accessed April 2015)
12. Eisai Data on File, 2015
13. Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007: 48(12) 2224 - 2233
14. Epilepsy Foundation. Types of seizures. Available at: http://www.epilepsy.com/learn/types-seizures . (Accessed May 2015)
15. Epilepsy Foundation. IGE Summary. Available at: http://www.epilepsy.com/information/professionals/about-epilepsy-seizures/idiopathic-gener alized-epilepsies . (Accessed July 2015)
16. Smithson WH et al, Curr Neurol Neurosci Rep 2014 Dec; 14(12):502
Date of preparation: September 2015
Job code: Fycompa-UK0221
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