In the ITT analysis set (n=1207), the frequency of all seizures decreased over the first 26 weeks of perampanel treatment in patients with at least 26 weeks' exposure to perampanel (n=1006 [83.3%]); this reduction was maintained in patients with at least one year of exposure (n=588 [48.7%]). The overall median percent changes in seizure frequency in patients included in each 13-week interval of perampanel treatment were -39.2% for weeks 13-26 (n=1114), -46.5% for Weeks 40-52 (n=731), and 58.1% for Weeks 92-104 (n=59). Overall responder rates in patients included in each 13-week interval of perampanel treatment were 41.4% for Weeks 13-26 (n=1114), 46.9% for Weeks 40-52 (n=731) and 62.7% for weeks 92-104 n=59). During the blinded conversion period, the reduction in seizure frequency in patients previously randomised to placebo (-42.4%, n=369) was similar to that in patients previously randomised to perampanel (-41.5%, n=817).
Treatment-emergent AEs were reported in 87.4% of patients. The most frequent were dizziness (43.9%), somnolence (20.2%), headache (16.7%), and fatigue (12.1%). Serious AEs were reported in 13.2% of patients.
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.[12],[13]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(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 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).
- Inovelon(R) (rufinamide) for the adjunctive treatment of seizures associated
with Lennox-Gastaut Syndrome in patients >4 years (Rufinamide was originally developed
by Novartis)
- Fycompa(R) (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, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Czech Republic, Slovakia, the Netherlands, Belgium, Russia 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... 12mg+film-coated+tablets/ 2. Rogawski MA. Epilepsy Currents 2011;11:56-63.
4. French JA. Refractory Epilepsy; Clinical Overview. Epilepsia 2007: 48 (Suppl1) 3 - 7
5. Krauss GM. et al. Randomized phase III study 306: Adjunctive perampanel for refractory partial-onset seizures. Neurology 2012; 78:1408-1415
6. French JA. Adjunctive perampanel for refractory partial-onset seizures: randomized phase III study 304. Neurology 2012;79:589-596
7. French JA et al. Evaluation of adjunctive perampanel in patients with refractory partial-onset seizures: Results of randomized global phase III study 305. Epilepsia 2012:1-9
8. Krauss GL et al. Perampanel, a selective, noncompetitive alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor antagonist, as adjunctive therapy for refractory partial-onset seizures: interim results from phase III, extension study 307. Epilepsia, 2013;54(1):126-34.
9. Ben-Menachem E,Krauss GL, Noachtar S et al. Abstract presented at ECE 2012
10. Steinhoff BJ, Gauffin H, McKee P et al. Abstract presented at ECE 2012
11. Trinka E, Straub H, Squillacote D et al. Abstract presented at ECE 2012
12. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe.
http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510... [http://www.ibe-epilepsy.org/downloads/EURO Report 160510.pdf ] [Accessed 18 July 2012].
13. Pugliatti M, et al. Epilepsia 2007: 48(12) 2224-2233.
Date of preparation: December 2013
Job code: Perampanel-UK2144
CONTACT: Media Enquiries: Eisai Europe Ltd, Cressida Robson / CharlotteAndrews , +44(0)7908-314-155/+44(0)7947-231-513 ,Cressida_Robson@eisai.net , Charlotte_Andrews@eisai.net. Tonic LifeCommunications, Frances Murphy/Nicola Lilley, +44(0)207-798-9262/+44-(0)207-798-9905, frances.murphy@toniclc.com, nicola.lilley@toniclc.com
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