New Data for Fycompa® (perampanel) and Inovelon® (rufinamide) Further Validate Long-Term Seizure Control and Safety Profile for Both Treatments Across a Range of Epilepsy Seizure Types

HATFIELD, England, September 8, 2016 /PRNewswire/ --





FOR EMEA MEDIA ONLY - NOT FOR SWISS/AUSTRIAN JOURNALISTS

Eisai present several abstracts on new data at 12th European Congress on Epileptology (ECE) for epilepsy treatments 

Data from several abstracts for Eisai's epilepsy treatments Fycompa(R) (perampanel) and Inovelon(R) (rufinamide) will be presented at the 12th European Congress on Epileptology (ECE), 11-15 September 2016, Prague, Czech Republic.  These new data augment previous evidence on the efficacy and safety for these agents in different epilepsy seizure types, including generalised tonic clonic seizures (primary and secondary), and Lennox-Gastaut Syndrome.

Perampanel is indicated in the European Union for the adjunctive treatment of partial-onset seizures, with or without secondary generalised seizures, and for primary generalised tonic clonic seizures, in patients with idiopathic generalised epilepsy (IGE) aged 12 years and older.[1] Rufinamide is indicated in the European Union as adjunctive therapy for the treatment of seizures associated with Lennox-Gastaut Syndrome in patients 4 years of age and older.[2]

"The data presented at ECE reinforce Eisai's continued focus on epilepsy treatment options that have the potential to improve outcomes in different patient populations. Epilepsy is a challenging condition to manage - those affected by it just want to get on with life through better seizure control and acceptable tolerability. Building the evidence for perampanel and rufinamide is therefore vital to enable clinicians to better understand and optimise treatment outcomes in clinical practice," comments Neil West, Vice President, Global Neurology Business Group, Eisai EMEA.

Data from several analyses will be presented for the 332 randomised, placebo-controlled, clinical trial[3] of adjunctive perampanel including an interventional open label extension study,[4] and post-hoc analyses of study 332[5] in myoclonic and absence seizures.

Abstract #0074 - Perucca E et al[6] - 12 September 11:30-13:00 

Adjunctive perampanel was associated with improved seizure control in patients with partial-onset seizures treated for up to four years (n=78) and particularly in subjects with secondary generalised seizures at baseline. No new safety signals were seen during long-term perampanel exposure.

Abstract #0073 - O'Brien T et al[5] - 14 September 11:30-13:00

Epilepsy drugs can paradoxically increase seizure activity, and most notably absence or myoclonic seizures.[7]   Outcomes in a post-hoc analysis of the 17-week core phase of study 332 showed that compared with placebo, adjunctive perampanel did not show clear evidence for worsening of myoclonic or absence seizures. However, the study was not powered to detect differences in these seizure types.

Abstract #P555 - Weschler R et al[4] - 14 September 13:00-14:30

In an interventional open label extension study,[4] 138 IGE patients with drug-resistant primary generalised tonic clonic seizures who received long-term adjunctive perampanel for up to 142 weeks (2.7 years), had a favourable risk-benefit ratio. Outcomes were consistent with the known safety profile for perampanel. A total 120 patients (87%) experienced treatment-emergent adverse events (AEs) including 20 (14.5%) with severe AEs, 18 (13%) with serious AEs, and 13 (9.4%) with AEs that lead to withdrawal.

Abstract #P590 - Auvin S et al[8]- 13 September 13:00-14:30 

Results from a recent European patient registry study[8] for safety in 111 patients of all ages (greater than or equal to4 years) with Lennox-Gastaut Syndrome suggest the potential for rufinamide and 'other' antiepileptic drugs in the long-term treatment of LGS. After 12 months, the proportion of patients rated as 'minimally', 'much', or 'very much' improved in control of all seizures was 47.6% (n=20/42) for rufinamide and 39.4% (n=13/33) for 'other' antiepileptic drugs. Treatment related adverse events were 40.6% for rufinamide and 27.7% for 'other' drugs.[8] The most frequently reported rufinamide-related adverse events (greater than or equal to5% patients) were somnolence (7.8%) and decreased appetite (6.3%).  

Abstract #P622 - Brandt C et al[9]- 14 September 13:00-14:30 

There are limited published data on the treatment of adults with Lennox-Gastaut Syndrome.  In analyses of a registry study,[8] data on adults (greater than or equal to18 years; n=24) were extracted and analysed.  At month 24, the proportion of patients rated as 'minimally', 'much', or 'very much' improved in control of all seizures was 71.4% (n=5/7) for rufinamide 50% (n=2/4) with 'other' antiepileptic drugs. Adverse events were seen in 50% of patients on rufinamide compared with 37.5% for 'other' drugs.[9]


Abstract Number
Timing of presentation Abstract details

Perampanel Marked Reduction in Secondarily Generalised Seizures
Abstract number: #0074 in Patients Treated With Perampanel for 3 and 4 Years
Platform Session 1 Emilio Perucca, Gregory L Krauss, Patrick Kwan,
Antiepileptic Drugs 1 Elinor Ben-Menachem, Xue-feng Wang, Jerry Shih,
Monday 12 September Betsy Williams, Antonio Laurenza, Haichen Yang
11.30 - 13.00
Congress Hall

Abstract number: #0073 Myoclonic and Absence Seizures in Patients With
Platform Session 13 Idiopathic Generalized Epilepsy (IGE): Exploratory
Antiepileptic Drugs 3 Outcomes in a Phase III PGTC Study With Adjunctive
Wednesday 14 September Perampanel
11.30 - 13.00 Terence J O'Brien, Bernhard J Steinhoff, Antonio
Forum Hall Laurenza, Anna Patten, Francesco Bibbiani, Haichen Yang

Abstract number: #P555 Long-term safety and efficacy of adjunctive
Poster Session perampanel in patients with drug-resistant primary
Pharmacology / AEDs 10 generalised tonic clonic seizures in idiopathic
Wednesday 14 September generalised epilepsy: results of an open-label extension
13.00 - 14.30 Robert T Wechsler, Jacqueline French, Eugen Trinka,
Poster Area (Forum Hall Christian Brandt, Terence O'Brien, Francesco
Foyer) Bibbiani, Anna Patten, Antonio Laurenza

Rufinamide
Abstract number: #P590 European non-interventional registry study of
Poster Session antiepileptic drug use in patients with
Pharmacology / AEDs 5 Lennox-Gastaut Syndrome
Tuesday 13th September Stéphane Auvin, Rob McMurray, Christian Brandt,
13.00 - 14.30 Marina Nikanorova
Poster Area (Forum Hall
Foyer)

Abstract number: #P622 Use of rufinamide and other antiepileptic drugs in
Poster Session the management of adult patients (greater than or
Pharmacology / AEDs 9 equal to18 years) with Lennox-Gastaut Syndrome
Wednesday 14 September Christian Brandt, Rob McMurray, Stéphane Auvin,
13.00 - 14.30 Marina Nikanorova
Poster Area (Forum Hall
Foyer)



The continued development of its epilepsy portfolio 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. Eisai is committed to the therapeutic area of neurology and to address the unmet medical needs of people with epilepsy and their families.

Notes to Editors 

About Fycompa(R) (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, approximately 52,000 people living with epilepsy across the EMEA region* have been treated with perampanel.[10]

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

Fycompa(R) (perampanel) - Study 332[3]

Study 332 is a double-blind, randomised, placebo-controlled, multicentre, parallel-group Phase III trial to evaluate the efficacy and safety of adjunctive perampanel for refractory PGTC seizures in idiopathic generalised epilepsy. 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) in 2007. Inovelon 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 in is available in the Denmark, France, Germany, Portugal, Spain, 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.[11] 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 nature and 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 contraction (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.[12],[13] PGTC seizures can also result in injury and sudden unexplained death in epilepsy (SUDEP).[14]

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 generalised epilepsy
and for partial onset seizures, with or without secondary generalisation, in patients
aged 12 years or older
- Inovelon(R) (rufinamide) 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) 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(R) (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 countries.

For more information about Eisai Co., Ltd., please visit http://www.eisai.com [https://webmail.hhealth.com/owa/redir.aspx?C=6OjkkH_Oz0KcpqZqtz0gYu5W64yst9IIliR8UZVYwgaeouwuOzC4BDQV-nJBoz6bpw7MInczpyk.&URL=http%3a%2f%2fwww.eisai.com%2f ]

References 

1.     Fycompa(R) (perampanel) SPC - Fycompa 2mg,4mg,6mg,8mg,10mg,12mg film-coated tablets. Available at: https://www.medicines.org.uk/emc/medicine/26951  [updated 1 March 2016].  Accessed August 2016 

2.     Inovelon(R) (rufinamide) SPC - Inovelon Tablets and Oral Suspension.  Available at: http://www.medicines.org.uk/emc/medicine/20165/SPC/ [http://www.medicines.org.uk/emc/medicine/20165/SPC ]  [updated 6 August 2013].  Accessed August 2016 

3.     French A, et al. Perampanel for tonic-clonic seizures in idiopathic generalised epilepsy.  Neurology  2015;85:950-57 

4.     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 #P555 

5.     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 

6.     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 

7.     Perucca E, et al.  Antiepileptic drugs as a cause of worsening seizures.  Epilepsia 1998;39(1):5-17 

8.     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 #P590 

9.     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 

10.     Eisai. Data on File 2016. DOF PER112 

11.     Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf (Accessed June 2016) 

12.     Epilepsy Foundation. Types of seizures. Available at: http://www.epilepsy.com/learn/types-seizures . (Accessed June 2016) 

13.     Epilepsy Foundation. IGE Summary. Available at: http://www.epilepsy.com/information/professionals/about-epilepsy-seizures/idiopathic-generalized-epilepsies/idiopathic . (Accessed June 2016) 

14.     Smithson WH, et al.  Sudden Unexpected Death in Epilepsy: Addressing the Challenges. Curr Neurol Neurosci Rep 2014; 14(12):502 


Eisai


CONTACT: Media EnquiriesEisai, Cressida Robson / Chloe Fox, +44 7908 314 155/+44 7508 355 171 ,Cressida_Robson@eisai.net, Chloe_Fox@eisai.net, Tonic Life Communications,Carys Thomas Ampofo / Chris Caudle, +44 7973 821 113 / + 44 7958 585 406,Carys.Thomas-Ampofo@toniclc.com, Chris.Caudle@toniclc.com

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