New Fycompa® (perampanel) Data on Long-term Seizure Control in Different Seizure Types Presented at the 12th European Co

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.

Since launch, approximately 52,000 people living with epilepsy across the EMEA region* have been treated with perampanel.[9]

*EMEA countries are Germany, Italy, United Kingdom, Spain, France, Switzerland, Netherlands, Ireland, Sweden, Norway, Denmark, Austria, Belgium, Czech Republic, Portugal, Greece, Australia, Russia, Slovakia, Israel.

Clinical data for Fycompa(R) (perampanel) - Phase III study 332[4] 

Study 332 is a double-blind, randomised, placebo-controlled, multicentre, parallel-group trial to evaluate the efficacy and safety of adjunctive perampanel for refractory primary generalised tonic clonic (PGTC) seizures in idiopathic generalised epilepsy (IGE). 164 people (greater than or equal to12 years old) with PGTC seizures and IGE (diagnoses confirmed by independent reviewers), despite treatment with one to three concomitant AEDs, were randomised to receive perampanel (8 mg/d or highest tolerated dose) or placebo in a 1:1 ratio.

About Inovelon(R) (rufinamide)   

Rufinamide was approved for adjunctive therapy for Lennox-Gastaut Syndrome in Europe (under the brand name Inovelon(R)) in 2007. Rufinamide 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 is available in Austria, Denmark, France, Finland, Germany, Netherland, Norway, Portugal, Spain, Switzerland, Sweden and the United Kingdom.

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.[10]  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 (sensory or psychic phenomena), which is followed by loss of consciousness and muscle rigidity (tonic phase). This is followed by violent muscle contractions (clonic phase). 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.[11],[12] PGTC seizures can also result in risk of injury and sudden unexpected death in epilepsy (SUDEP).[13]

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) is indicated for use as a once-daily, adjunctive therapy
for both primary generalised tonic clonic seizures in idiopathic generalisation and
for partial onset seizures, with or without secondary generalisation, in patients with
epilepsy aged 12 years or older
- Inovelon(R) (rufinamide) is indicated for the adjunctive treatment of seizures
associated with Lennox-Gastaut Syndrome in patients greater than or equal to4 years.
(Rufinamide was originally developed by Novartis)
- Zonegran(R) (zonisamide) is indicated 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(R) is under license from the originator Dainippon Sumitomo Pharma)
- Zebinix(R) (eslicarbazepine acetate) is indicated as adjunctive therapy in adult
patients with partial onset seizures, with or without secondary generalisation
(Zebinix(R) 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. Wechsler R, et al. Long-term safety and efficacy of adjunctive perampanel in patients with drug-resistant primary generalised tonic clonic seizures in idiopathic generalised epilepsy: results of an open-label extension; European Congress on Epileptology 2016: Abstract #555

2. Fycompa(R) (perampanel) Summary of Product Characteristics (last updated March 2016). Available at: http://www.medicines.org.uk/emc/medicine.... Accessed September 2016

3. O'Brien T, et al. Myoclonic and Absence Seizures in Patients With Idiopathic Generalised Epilepsy (IGE): Exploratory Outcomes in a Phase III PGTC Study With Adjunctive Perampanel; European Congress on Epileptology 2016: Abstract #0073

4. French J, et al. Perampanel for tonic clonic seizures in idiopathic generalised epilepsy. Neurology 2015;85 (11):950-57

5. Perucca E, et al. Marked Reduction in Secondarily Generalised Seizures in Patients Treated With Perampanel for 3 and 4 Years; European Congress on Epileptology 2016: Abstract #0074

6. Auvin S, et al. European non-interventional registry study of antiepileptic drug use in patients with Lennox-Gastaut Syndrome; European Congress on Epileptology 2016: Abstract #590

7. Inovelon(R) (rufinamide) SPC - Inovelon Tablets and Oral Suspension. Available at: http://www.medicines.org.uk/emc/medicine... 6 August 2013]. Accessed September 2016

8. Brandt C, et al. Use of rufinamide and other antiepileptic drugs in the management of adult patients (greater than or equal to18 years) with Lennox-Gastaut Syndrome; European Congress on Epileptology 2016: Abstract #P622

9. Eisai. Data on File 2016. DOF PER112

10. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.... Accessed September 2016

11. Epilepsy Foundation. Types of Seizures. Available at: http://www.epilepsy.com/learn/types-seizures. Accessed September 2016

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