Pooled Phase III Data Presented at the American Epilepsy Society (AES) Annual Meeting on the Use of Fycompa® (Perampanel) in the Treatment of Primary and Secondary Generalised Tonic Clonic Seizures

HATFIELD, England, December 8, 2015 /PRNewswire/ --

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

Abstracts provide a wealth of data to support the use of perampanel in patients with primary and secondary generalised tonic clonic seizures   

Data at the American Epilepsy Society (AES) 69th Annual Meeting Philadelphia, show that Fycompa^® (perampanel) treatment reduces primary and secondary generalised tonic clonic seizures and is well tolerated versus placebo. Results from a post-hoc analysis demonstrate treatment with perampanel was associated with a greater 50% responder rate versus placebo (61.8% vs 37.8%; p<0.0001) and conferred a median 65.5% reduction in primary and secondary generalised seizure frequency over 28 days versus placebo (-24.6; p<0.0001).^[1]

The analysis evaluated the efficacy and tolerability of 8mg/day perampanel on 492 people with primary or secondary generalised tonic clonic seizures, across four phase III studies. 26.9% of participants achieved seizure-free status with perampanel compared to 12.6% of people with placebo. Treatment with perampanel was well tolerated.^[1]

"Findings from this pooled analysis of Phase III data provide an important look into the efficacy and tolerability of perampanel in people with primary and secondary generalised tonic clonic seizures. It is encouraging that this examination of perampanel has shown it to offer a median 65.5% reduction in primary and secondary generalised seizures against placebo," comments Professor Eugen Trinka, Professor and Chair of the Department of Neurology, Paracelsus Medical University, Salzburg, Austria.

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.^[2]

Additional analyses of an open-label extension study of perampanel show it provides a long-term marked reduction in seizures in people with drug-resistant partial seizures regardless of baseline seizure frequency. The sub-analysis examines data from 1,217 participants who were grouped into those with a baseline seizure frequency <11.2 per 28 days (n=609) and those with a baseline seizure frequency >11.2 per 28 days (n=608). During the maintenance period of the open label extension study, there was no pattern showing a difference between the groups and perampanel treatment showed a reduction in seizure frequency over time.^[3]

Further sub-analyses of the Phase III study 332 (evaluating the adjunctive treatment of primary generalised tonic clonic seizures in patients with idiopathic generalised epilepsy) examine the efficacy and safety of perampanel by baseline antiepileptic drug,^[4] clinical laboratory evaluation and adverse events related to cardiac, liver and renal disorders,^[5] suicidal behaviour and ideation,^[6] falls,^[7] psychiatric or behavioural events.^[8] An additional post hoc analysis of data pooled from studies 304, 305 and 306 examines the effect of the duration of epilepsy on perampanel treatment.^[9]

An additional series of abstracts present the efficacy and tolerability results from a Phase II study of perampanel in 114 adolescents between the ages of 12 and 18 with inadequately controlled partial onset seizures. At weeks 40-52, the median reduction in total seizure frequency compared to baseline was 74.1% and the mean responder rate was 66%.^[10] Data from this study on the 114 adolescents show that compared to baseline, perampanel does not have a clinically meaningful effect on growth and development^[11] and has minimal overall cognitive effects on adolescent patients.^[12]

Finally, preliminary efficacy results from a pilot Study 232 explore the safety and efficacy of perampanel as an oral suspension in children between 2 and 12 with epilepsy.^[13]

"We are very pleased to have a wealth of data on the efficacy and tolerability of perampanel at AES 2015. This meeting marks a record abstract submission for perampanel, with the presentation of 27 abstracts," comments Antonio Laurenza, Executive Director, Eisai Inc.

The development of perampanel demonstrates Eisai's commitment to 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^® (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 39,588 people living with epilepsy across Europe.^[14]

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.^[15] 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.^[16],[17]  PGTC seizures can also result in risk of injury and sudden unexplained death in epilepsy (SUDEP).^[18]

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) 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 older
• Inovelon^® (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients >4 years. (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 six years and above. (Zonegran is under license from the originator Dainippon Sumitomo Pharma)
• Zebinix^® (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

References  

1. O'Brien T, et al. Efficacy and Tolerability of Perampanel in Patients (Pts) with Secondarily Generalized (SG) or Primary Generalized Tonic-Clonic Seizures (PGTCS): a Pooled Analysis of Four Randomized, Phase III Studies. Poster 2.250 at AES 2015

2. Fycompa, Summary of Product Characteristics. Available at: http://www.medicines.org.uk/emc/medicine/26951/ (Accessed November 2015)

3. Williams B, et al. Efficacy of Perampanel by Baseline Seizure Frequency in Patients with Partial Seizures (Phase III Double-Blind Studies). Poster 1.188 at AES 2015

4. Kirmani B, et al. Subanalysis by Baseline Antiepileptic Drugs (AEDs): Results From Perampanel Study 332 in Patients With Primary Generalized Tonic-Clonic Seizures (PGTCS). Poster 1.191 at AES 2015

5. McElveen A, et al. Clinical Laboratory Evaluation and TEAEs Related to Cardiac, Hepatic and Renal Disorders: Perampanel PGTC Phase III Study. Poster 1.195 at AES 2015    

6. Ettinger A, et al. Suicidality Events in Patients With Primary Generalized Tonic-Clonic Seizures (PGTCS): A Review of Study 332. Poster 1.189 at AES 2015

7. Leppik I, et al. Analysis of Falls in the Phase III Perampanel Study of Primary Generalized Tonic-Clonic Seizures (PGTCS).  Poster 1.194

8. Dobrinsky C, et al. Psychiatric and Behavioral Events with Perampanel in Patients with Primary Generalized Tonic-Clonic Seizures (PGTCS): Study 332. Poster 1.190 at AES 2015

9. Halford J, et al. Effect of Duration of Epilepsy on Adjunctive Perampanel Treatment in Patients with Drug-Resistant Partial Seizures. Poster 1.193 at AES 2015

10. Villanueva V, et al. Efficacy and Safety of Adjunctive Perampanel (Per) in Adolescents with Inadequately Controlled Partial-Onset Seizures (POS): Randomized, Double-Blind and Open-Label Extension (OLE) Study. Poster 2.263 at AES 2015

11. Kumar D, et al. Effect of Adjunctive Perampanel on Growth and Development in Adolescents with Inadequately Controlled Partial-Onset Seizures (POS): Randomized, Double-Blind and Open-Label Extension (OLE) Study. Poster 3.262 at AES 2015

12. Fain R, et al. Long-Term Cognitive Effects of Adjunctive Perampanel (Per) in Adolescents for Treatment of Partial-Onset Seizures (POS): Randomized, Double-Blind and Open-Label Extension (OLE) Study. Poster 3.260 at AES 2015

13. Davis R, et al. Effect of Adjunctive Perampanel in Pediatric Subjects with Epilepsy: Preliminary Safety and Efficacy Results From Study 232. Poster 1.184 at AES 2015

14. Eisai Data on File, 2015

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

16. Epilepsy Foundation. Types of seizures. Available at: http://www.epilepsy.com/learn/types-seizures . (Accessed November 2015)

17. Epilepsy Foundation. IGE Summary. Available at: http://www.epilepsy.com/information/professionals/about-epilepsy-seizures/idiopathic-generalized-epilepsies . (Accessed November 2015)

18. Smithson WH et al, Curr Neurol Neurosci Rep 2014 Dec; 14(12):502

Date of preparation: November 2015
Job code: Fycompa-UK0243