New Data Show That 30% of People Were Free of Primary Generalised Tonic Clonic Seizures When Using Adjunctive Fycompa® (perampanel)

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Eisai Europe Limited

08 Dec, 2014, 00:01 GMT

HATFIELD, England, December 8, 2014 /PRNewswire/ --


Press release for EU media only: not for Swiss/U.S. Journalists

New data presented by Eisai at the American Epilepsy Society (AES) annual meeting highlight efficacy and safety of perampanel to treat most severe form of epilepsy 

Eisai presents new Phase III data at the American Epilepsy Society (AES) Annual Meeting in Seattle, Washington, of Fycompa® (perampanel) as adjunctive therapy for primary generalised tonic-clonic seizures (PGTC). Perampanel is currently indicated for the adjunctive treatment of partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.[1]

Perampanel is the only licensed anti-epileptic drug (AED) to selectively target AMPA receptors, a protein in the brain which plays a critical role in the spread of seizures.[1] This mechanism of action is different to all other, currently available AEDs. In addition, perampanel has the added benefit of convenient, once-daily dosing at bedtime[1] and, significantly, is the only new-generation partial epilepsy treatment approved to treat adolescents (>12 years) with epilepsy from launch.

"This research has underlined the potential that perampanel has for people living with primary generalised tonic-clonic seizures. These data, together with the novel mechanism of action of perampanel and the convenience of a once-daily dose at bedtime, make it an important prospective treatment for people living with primary generalised tonic-clonic seizures," commented Professor Eugen Trinka, Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University, Salzburg, Austria.

The results from study 332 demonstrate that perampanel significantly reduces primary generalised tonic-clonic seizure frequency and improves responder rates (≥50% reduction in seizure frequency per 28 days in the maintenance period, relative to baseline), the study's two primary outcome measures, when compared to placebo.[2] The study showed that adjunctive treatment with perampanel improved seizure control in people with idiopathic generalised epilepsy aged 12 years and over who were living with inadequately controlled primary generalised tonic-clonic seizures. 30.9% using perampanel were free of tonic-clonic seizures and it was well tolerated with a safety profile similar to refractory partial-onset seizures.

Epilepsy is one of the most common neurological conditions in the world. In Europe, at least six million people live with epilepsy, and 15 million Europeans will have one seizure at some time in their lives.[3] Currently, between 20-40% of patients with newly diagnosed epilepsy will become refractory to treatment.[4] Generalised tonic-clonic seizures are one of the most dangerous types of seizure.[5] 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.[6]

"These new data presented at AES will support the EU filing for perampanel as adjunctive therapy in the treatment of primary generalised tonic-clonic seizures," commented Dr Makarand Bagul, Director, Neurology EMEA Eisai Medical Strategy Lead.

Discovered and developed by Eisai in Europe and Japan, perampanel is manufactured in the UK and was approved by the European Commission on 23 July 2012. Perampanel is now approved in more than 35 countries worldwide. Eisai submitted a Marketing Authorisation Application to the European Commission in August 2014 for an indication expansion for perampanel to include the adjunctive treatment of PGTC seizures in people with epilepsy.  

The on-going clinical investigation of perampanel for different seizure types 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.

Notes to Editors 

About Fycompa® (perampanel) 

Perampanel is indicated for the adjunctive treatment of partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.[1]

Perampanel is a highly selective, non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid)-type glutamate receptor antagonist that has demonstrated seizure reduction in Phase II and III studies. 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.[1]

Further information for healthcare professionals can be found at http://www.fycompa.eu  

About Study 332[2]

Study population: 164 patients aged 12 years and older with PGTC seizures receiving one to maximum of three anti-epileptic drugs

Primary objective: To demonstrate the efficacy of adjunctive perampanel therapy compared to placebo on PGTC seizures

Treatment administered: (Placebo controlled) Perampanel oral tablets, once daily, up to 8 mg/day (titration phase), randomised dose 8 mg/day (maintenance phase)

Duration of treatment: Pre-randomisation phase (screening and baseline periods): up to 12 weeks

Randomisation phase (treatment): 17 weeks (titration phase, 4 weeks; maintenance phase, 13 weeks)

Extension phase: Over 38 weeks

Study locations: U.S., Europe, Japan, Asia

Primary endpoint: Percent change in PGTC seizure frequency (US):

  • Percent change from baseline in PGTC seizure frequency per 28 days during treatment

Responder rate (EU):

  • Percentage of patients who experience a 50% or greater reduction in PGTC seizure frequency per 28 days in the maintenance period relative to baseline

About Primary Generalised Tonic-Clonic Seizures 

Generalised tonic-clonic seizures are one of the most dangerous types of seizure.[5] For the majority of patients, a primary generalised tonic-clonic (PGTC) seizure begins with a loss of consciousness without any prior warning symptoms and a sudden contraction of the tonic muscles, causing the patient to fall down (tonic phase).[5] This is followed by violent convulsions (clonic phase) until the muscles finally relax, and the patient is left with a disturbance of consciousness.[6] 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.

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.[7] 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.

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
  • 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)
  • 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)

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. Fycompa, Summary of Product Characteristics (updated September 2014) http://www.medicines.org.uk/emc/medicine/26951/

2. French J et al. Adjuctive perpampanel for treatment of drug-resistant primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy: a double blind, randomised, placebo-controlled phase III trial.

Presented at AES 2014. Abstract #2.389

3. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe 2010. Available at; http://www.ilae.org/Visitors/Documents/ILAEAnnual-Report2010Final_000.pdf (Accessed December 2014)

4. French JA. Refractory Epilepsy; Clinical Overview. Epilepsia 2007: 48 (Suppl1) 3 - 7

5. Blumenfeld H et al. Cortical and subcortical networks in human secondarily generalized tonic-clonic seizures. Brain. 2009:132:999-1012

6. Epilepsy Action. Generalised seizures. https://www.epilepsy.org.uk/info/seizures/generalised-seizures (accessed July 2014)

7. Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007:48(12):2224-2233

Job code: Perampanel-UK2182
Date of preparation: December 2014