Neurology® Publishes Results From Pivotal Study of Eisai's Investigational Epilepsy Treatment perampanel

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Eisai Europe Limited

18 Apr, 2012, 20:15 GMT

HATFIELD, England, April 18, 2012 /PRNewswire/ --

This press release is for European media only

Eisai today announces the publication of results from a pivotal Phase III study[1] of perampanel, an investigational, highly selective, non-competitive AMPA-type glutamate receptor antagonist developed as an adjunctive therapy for partial seizures in adult patients with epilepsy.

The Study 306 data, published today in Neurology®, provides evidence that, as an adjunctive therapy, 4 and 8 mg/day doses of perampanel are effective and well-tolerated in reducing uncontrolled partial-onset seizures (with or without secondary generalisation) when compared with placebo.[1] Efficacy in seizure reduction was seen despite treatment with up to three other anti-epilepsy drugs (AEDs).[1] The results from Study 306 are one of three pivotal Phase III studies in the EXPLORE (EXamining Perampanel Observations from Research Experience) clinical trial programme.

Marketing authorisation applications for perampanel are currently under review with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

The development of perampanel underscores Eisai's human health care mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and well being of people worldwide.  Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of patients and their families.

Notes to Editors

About Perampanel

Eisai is currently developing perampanel for the potential adjunctive therapy of partial seizures in patients with epilepsy. Perampanel is a highly selective, non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid)-type glutamate receptor antagonist that has demonstrated seizure reduction in Phase II and III studies. 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, neurodegenerative disorders, movement disorders, pain and psychiatric disorders. If approved, perampanel will be the first product in this class for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older.

Study 306, the first in the Phase III EXPLORE (Examining Perampanel Observations from Research Experience) trials, set out to evaluate the efficacy and safety of perampanel (2, 4, and 8 mg/day) added to 1-3 concomitant AEDs in patients with uncontrolled partial-onset seizures. 706 patients were randomised and received trial medication (623 completed the trial). The primary endpoint for the EMA is 50% responder rate and the FDA is median percent change in seizure frequency. During this double-blind, placebo-controlled trial, patients with persisting seizures on 1-3 AEDs were randomised to perampanel 2, 4, and 8 mg/day or placebo following a 6-week baseline phase. Perampanel was titrated weekly by 2 mg/day and maintained at the dose achieved for 13 weeks. Analysis of covariance was performed on all treated patients with any seizure data (recorded in daily diaries) in the double-blind phase.

About Epilepsy

Epilepsy is one of the most common neurological conditions in the world, affecting approximately eight in 1,000 people in Europe.[2] There are an estimated 6 million people living with epilepsy in Europe[3], and an estimated 50 million people with the condition worldwide.[3] 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. Epilepsy has many possible causes but often the cause is unknown.

About Eisai Europe 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 the European market.

In Europe, Eisai currently has three marketed treatments including:

  • Zonegran® (zonisamide) as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation
  • Zebinix® (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalization
  • Inovelon® (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients >4 years

About Eisai

Eisai is one of the world's leading R&D-based pharmaceutical companies and has defined its corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call human health care (hhc). Eisai recently expanded their UK Hatfield facility which now supports the company's growing European, Middle Eastern and African (EMEA) business.

Eisai concentrates its R&D activities in three key areas:

  • Neuroscience, including: Alzheimer's disease, multiple sclerosis, neuropathic pain, epilepsy, depression
  • Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc and supportive cancer therapies; pain relief, nausea
  • Vascular/Immunological reaction including: acute coronary syndrome, atherothrombotic disease, rheumatoid arthritis, psoriasis, Crohn's disease

With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 11,000 people worldwide. In Europe, Eisai undertakes sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Iceland, Czech Republic, Slovakia, the Netherlands, and Belgium.

For further information please visit our web site http://www.eisai.com

References

1. Krauss GM. Serratosa JM, Villanueva V et al. Randomized Phase III study 306: adjunctive perampanel for refractory partial-onset seizures. Neurology 2012: Please visit: http://www.neurology.org/

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

3. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [Accessed 10 April 2012]