COMUNICADO: Wealth of Data for Fycompa® (perampanel) and Inovelon® (rufinamide) to be Presented at the American Epilepsy Society (AE

Publicado 28/11/2016 1:02:08CET

HATFIELD, England, November 28, 2016 /PRNewswire/ --


Data from nine abstracts for Eisai's epilepsy treatments perampanel and rufinamide will be presented at the 70th Annual Meeting of the American Epilepsy Society (AES), 2-6 December, Houston, Texas, which provide further insight into their long-term use in people with epilepsy.

Perampanel is indicated in the European Union for patients aged 12 years and older, for adjunctive treatment of partial-onset seizures (POS), with or without secondarily generalised seizures, and for adjunctive treatment of primary generalised tonic-clonic (PGTC) seizures in patients with idiopathic generalised epilepsy (IGE).[1]

Rufinamide is indicated in the European Union for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients with epilepsy aged four years and older.[2]

"These data provide real world insights into the activity of perampanel and rufinamide in potential patients over a wide range of ages. Through new and continued research with perampanel and rufinamide, we aim to further educate the epilepsy community about these debilitating diseases," comments Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai.

The 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 neurological conditions and their families.

Perampanel abstracts at AES (presented in the George R Brown Convention Center, Hall A3, Level 3): 

Abstract Number Abstract details

Poster # 2.189 Evaluation of perampanel as monotherapy for focal
Date: Sunday 4 seizures: experience from open-label extension studies
Time: 10:00-16:00
Location: Hall A3, Kwan P, Mintzer S, Laurenza A, Patten A, Cartwright K

Poster # 2.190 Adjunctive perampanel (PER) in patients (pts) with partial
Date: Sunday 4 seizures or primary generalized tonic-clonic seizures
December (PGTCS): effect of age at diagnosis
Time: 10:00-16:00
Location: Hall A3, Kramer L, Patten A, Laurenza A, French JA

Poster # 2.193 Long-term efficacy and safety of adjunctive perampanel:
Date: Sunday 4 pooled analyses of the open-label extension (OLE) studies
Time: 10:00-16:00
Location: Hall A3, Rektor I, Krauss GL, Inoue Y, Kaneko S, Williams B, Patten
B3 A, Bibbiani F, Laurenza A, Wechsler RT

Poster # 2.222 A systematic review of real world perampanel treatment
Date: Sunday 4 outcomes
Time: 10:00-16:00
Location: Hall A3, Krauss G, Tsong W, Steinhoff BJ

Poster # 2.225 An indirect treatment comparison (ITC) of perampanel
Date: Sunday 4 versus brivaracetam in patients with partial-onset
December seizures with or without secondary generalisation
Time: 10:00-16:00
Location: Hall A3, Tsong W, Kockelmann E, Tremblay G, Mehlig H, and Patel V

Poster # 3.238 Adjunctive perampanel in patients with drug-resistant
Date: Monday 5 partial seizures with and without concurrent vagal nerve
December stimulation therapy in Phase III studies
Time: 08:00-14:00
Location: Hall A3,
B3 Laurenza A, Klein P, Williams B, Patten A

Poster # 2.191 Phase II trials of adjunctive perampanel in Japanese
Date: Sunday 4 patients with refractory partial-onset seizures, an
December open-label, ascending-high-dose study (study 231) and
Time: 10:00-16:00 long-term extension study (study 233)
Location: Hall A3,
B3 Hiramatsu H, Saeki K, Ohnishi A, Kaneko S, Inoue Y

Poster # 3.232 Factors influencing the efficacy of perampanel:
Date: Monday, multivariate analysis of a randomized, double-blind,
December 5 placebo-controlled Phase III study
Time: 08:00-14:00
Location: Hall A3,
B3 Nishida T, Inoue Y, Kaneko S, Saeki K, Ishikawa K

Rufinamide abstracts at AES (in the George R Brown Convention Center, Hall A3, Level 3) : 

Abstract Number Abstract details

Poster # 3.363 Safety and Cognitive Development Effects of Adjunctive
Date: Monday 5 Rufinamide in Pediatric Subjects With Inadequately
December Controlled Lennox-Gastaut Syndrome (LGS): Final Results
Time: 08:00-14:00 From Study 303
Arzimanoglou A, Ferreira J, Satlin A, Olhaye O, Kumar D,
Location: Hall A3, Dhadda S, Bibbiani F

Notes to Editors 

About Fycompa(R) (perampanel)  

Perampanel is a first-in-class, non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) glutamate receptor antagonist on post-synaptic neurons.[1] 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.[3] Since launch, approximately 52,000 people living with epilepsy have been treated with perampanel.[4]

About Inovelon(R) (rufinamide)  

Rufinamide is a triazole derivative that is structurally unrelated to currently marketed antiepileptic drugs (AEDs).[5],[6] It is believed to regulate the activity of sodium channels in the brain which carry excessive electrical charges.[5] Rufinamide was approved for adjunctive therapy for seizures associated with Lennox-Gastaut Syndrome in Europe (under the brand name Inovelon) in 2007 in patients four years of age and older. Rufinamide is available as film-coated tablets containing 100mg, 200mg and 400mg rufinamide and as a 40mg/ml oral suspension.[2]

About Epilepsy  

Epilepsy is one of the most common neurological conditions in the world, affecting approximately six million 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 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.


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