HATFIELD, England, August 24, 2015 /PRNewswire/ --

PRESS RELEASE FOR EU MEDIA ONLY: NOT FOR AUSTRIA/SWISS/U.S. JOURNALISTS 

Newly published data evaluates the safety and efficacy of adjunctive perampanel for idiopathic generalised epilepsy 

Pivotal, global phase III study results for Fycompa^® (perampanel) in primary generalised tonic-clonic (PGTC) seizures are published for the first time today in Neurology.^[1] Study 332 assesses the safety and efficacy of perampanel compared to placebo, in primary generalised tonic-clonic (PGTC) seizures in idiopathic generalised epilepsy (IGE). Perampanel, which received the new indication from the European Commission (EC) on 24 June 2015, is the first new treatment for PGTC seizures in five years.^[2]

One third more patients treated with perampanel experience a 50% responder rate, which is statistically significant versus placebo (50% responder rate 64.2% vs 39.5%, respectively; P=0.0019).^[1] Perampanel also demonstrates a reduction in PGTC seizure frequency (per 28 days) versus placebo (76.5% vs 38.4%, respectively; P<0.0001).^[1] Furthermore, 31% of patients are seizure free during the 13-week maintenance period when treated with perampanel as an adjunctive therapy, compared to 12% in the placebo group.^[3] The adverse event profile is similar to that for other perampanel studies, the most common treatment-emergent adverse events were dizziness, fatigue, headache, somnolence and irritability.^[1]

This is the only study in which the presence of IGE with PGTC seizures was confirmed by an independent expert committee. The study shows that perampanel is well tolerated and improves the control of PGTC seizures in patients who are still experiencing seizures despite their current treatment. The results indicate that perampanel can be considered a broad-spectrum AED, so effective with both focal- and generalised-onset seizures." comments Christian Brandt, Head of Dept. of General Epileptology, Bethel Epilepsy Centre.

Study 332 was conducted amongst 164 patients aged 12 years and older with IGE who experience PGTC seizures who receive one to a maximum of three anti-epileptic drugs across centres in Europe, the U.S., Japan and Asia.^[1]

Generalised tonic-clonic seizures can be a dangerous type of epilepsy,^[4] which increase the risk of injury, such as fractured bones, shoulder dislocation and burns.^[5] PGTC seizures also increase the risk of sudden unexplained death in epilepsy (SUDEP) and are known to lead to absence status epilepticus (ASE), seizures that last for extended time periods. The seizures start with a loss of consciousness and a sudden contraction of the muscles, which can cause the person to fall down (tonic phase). This is followed by violent convulsions (clonic phase) until the muscles finally relax. While the seizure generally only lasts a few minutes, the person will often feel confused or drowsy for a few minutes or up to a few days before returning to normal.^[4],[6] Despite treatment, around 20% of people with idiopathic generalised epilepsy remain uncontrolled.^[7]

Perampanel is the only licensed anti-epileptic drug (AED) to selectively target initiation and spread of seizures through inhibition of AMPA receptors, a protein in the brain which plays a critical role in the spread of seizures.^[8] In addition to PGTC seizures in IGE, perampanel was originally indicated for the adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.^[9]

The continued development of perampanel underscores Eisai's human health care mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and well-being of people worldwide. Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of patients with epilepsy and their families. Eisai is proud to market more epilepsy products in EMEA than any other company.

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.

Since launch perampanel has helped treat 33,496 people living with epilepsy across Europe.^[9]

About Study 332^[1]

This Phase III, double-blind, randomised, placebo-controlled, multicentre, parallel-group trial evaluates the efficacy and safety of adjunctive perampanel for refractory tonic-clonic seizures, compared to placebo, amongst 164 patients aged 12 years and older with PGTC seizures receiving one to maximum of three anti-epileptic drugs. The study was conducted across centres in the U.S., Europe, Japan and Asia.

Perampanel was administered via oral tablets, once daily, up to 8 mg/day (titration phase) and then maintained on maximum tolerated dose (maintenance phase). The study period was divided into the pre-randomisation phase (screening and baseline periods): up to 12 weeks, the randomisation phase (treatment): 17 weeks (titration phase, 4 weeks; maintenance phase, 13 weeks) followed by an extension phase.

Results demonstrate that perampanel significantly reduces the number of PGTC seizures (≥50% reduction in seizure frequency per 28 days in the maintenance period, relative to baseline), the study's primary outcome measure, when compared to placebo. Perampanel was generally well tolerated, the most frequent adverse events (10% in the perampanel arm and greater than placebo) were dizziness, fatigue and headache, irritability and somnolence. The adverse event profile in this study is similar to that for other perampanel studies.  

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] 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.^[4],[6] PGTC seizures can also result in risk of injury and sudden unexplained death in epilepsy (SUDEP).^[11]

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) 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 partial onset seizures, with or without secondary generalised seizures, in patients with epilepsy aged 12 years or older.
• Inovelon^® (rufinamide) for the adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients four years of age and older (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 6 years and above (Zonegran is under license from the originator Dainippon Sumitomo Pharma)
• Zebinix^® (eslicarbazepine acetate) as adjunctive therapy in adults with partial onset seizures, with or without secondary generalisation (Zebinix is under license from BIAL). Eisai received a sole license to market, promote and distribute Zebinix^® in the following European Countries: Austria, Belgium, Bulgaria, Czech Republic, Belarus, Bosnia, Croatia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Monaco, Netherlands, Norway, Poland, Romania, Russia, Serbia, Slovakia, Slovenia, Spain (co-promotion with Bial from launch) Sweden, Switzerland, Turkey, Ukraine and the United Kingdom

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. French JA et al. Perampanel for tonic-clonic seizures in idiopathic generalized epilepsy: A randomized trial. Neurology 2015. Available at: http://m.neurology.org/content/early/2015/08/21/WNL.0000000000001930.abstract?sid=a7fb2575-996d-4854-8c6c-ac5c791191d2 . Last Accessed August 2015
2. Eisai. Data on file. 2015
3. French J et al. Adjunctive Perampanel RCT for PGTC seizures. Association of British Neurologists annual meeting 2015; Abstract #53141
4. Epilepsy Foundation. Types of seizures. Available at: http://www.epilepsy.com/learn/types-seizures . Last Accessed May 2015
5. Asadi-Pooya AA et al. Physical injuries in patients with epilepsy and their associated risk factors. Seizure 2012 Apr;21(3):165-8
6. Epilepsy Foundation. IGE Summary. Available at: http://www.epilepsy.com/information/professionals/about-epilepsy-seizures/idiopathic-generalized-epilepsies . Last Accessed July 2015
7. Faught E. Treatment of refractory primary generalized epilepsy. Rev Neurol Dis 2004;1:S34-S43
8. Rogawski MA. Revisiting AMPA receptors as an antiepileptic drug target. Epilepsy Currents 2011;11:56-63.9.
9. Eisai Data on File, 2015
10. Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007: 48(12) 2224 - 2233
11. Smithson WH et al, Curr Neurol Neurosci Rep 2014 Dec; 14(12):502

Date of preparation: June 2015    
Job code: Fycompa-UK0203

SOURCE Eisai