Eisai Initiates Two Phase III Clinical Studies for Fycompa® (Perampanel) in Young Children With Partial-Onset (Focal) Seizures and Lennox-Gastaut Syndrome

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

FOR UK MEDIA ONLY - NOT FOR SWISS/AUSTRIAN JOURNALISTS

Eisai today announces the initiation of two global multicentre, Phase III clinical studies to assess perampanel in children aged four to eleven with inadequately controlled partial-onset (focal) seizures or primary generalised tonic-clonic (PGTC) seizures (Study 311), and patients aged two years and older with seizures associated with Lennox-Gastaut Syndrome (Study 338).

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

About Study 311[2] (perampanel in children aged four to eleven)

Study 311 is a global multicentre, open-label, single-arm trial with an extension phase, to evaluate the safety, tolerability and exposure-efficacy relationship of perampanel oral suspension when administered as an adjunctive therapy in approximately 160 children (ages 4 to less than 12 years) with inadequately controlled partial-onset seizures or primary generalized tonic-clonic seizures. Following the 23 week treatment phase in which patients are titrated on the basis of individual clinical response and tolerability. Long term safety will be assessed during an extension phase.

About Study 338[3] (perampanel in patients with Lennox-Gastaut Syndrome)  

Study 338 is a global double-blind, randomised, placebo-controlled trial with an open-label extension to evaluate the efficacy and safety of adjunctive perampanel in approximately 140 participants at least 2 years of age with inadequately-controlled seizures associated with Lennox-Gastaut Syndrome. Patients will be titrated to receive up to 8 mg of perampanel orally once-daily or matching placebo. The primary outcome measure is median percentage change in drop seizure frequency per 28 days during double-blind treatment up to 18 weeks.

Lennox-Gastaut Syndrome is a debilitating form of childhood-onset epilepsy that most often appears in children aged 2-7. It is characterised by frequent and multiple seizure types, often accompanied by delayed intellectual development. Although the incidence is estimated to 0.1 in 100,000 inhabitants per year, the prevalence is high in people with epilepsy (5-10 per cent), representing 1-2 per cent of all childhood epilepsies[4].

"We are committed to helping children with epilepsy manage their condition through the continued development of treatment options such as perampanel. Through the initiation of these two clinical trials we hope to improve our understanding of perampanel in children with epilepsy," comments
Dr. Lynn Kramer, Chief Clinical Officer and Chief Medical Officer, Eisai Neurology Business Group.

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 epilepsy and to address the unmet medical needs of people with epilepsy and their families.

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.

Since launch, an estimated 52,000 people living with epilepsy across Europe and Australia have been treated with perampanel[5].

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[6]. 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, Oceania (EMEA). In the EMEA region, Eisai currently has four marketed treatments including:

• Fycompa^® (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 with epilepsy aged 12 years and older
• Inovelon^® (rufinamide) is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients four years of age and older. (Rufinamide was originally developed by Novartis)
• Zonegran^® (zonisamide) is indicated as monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy and as an adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents and children aged six years and older. (Zonegran^® is under license from the originator Dainippon Sumitomo Pharma)
• Zebinix^® (eslicarbazepine acetate) is indicated 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]Fycompa® (perampanel) Summary of Product Characteristics (last updated March 2016). Available at: http://www.medicines.org.uk/emc/medicine/26951. Accessed September 2016

[2] https://clinicaltrials.gov/ct2/show/NCT02849626?term=fycompa&rank=28

[3] https://clinicaltrials.gov/ct2/show/NCT02834793?term=fycompa&rank=12

[4] Tyagi S, et al . Pharmacological management of Lennox-Gastaut Syndrome-a difficult-to-treat form of childhood-onset epilepsy: an overview. International Journal of Pharma and Bio Sciences. 2010:1(3).

[5] Eisai. Data on File 2016. DOF PER112

[6] Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. Available at: http://www.who.int/mental_health/neurology/epilepsy/euro_report.pdf

November 2016

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