New Data for Fycompa® (perampanel) and Inovelon® (rufinamide) Further Validate Long-Term Seizure Control and Safety Prof

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.as... ]

References 

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

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