Study Shows Fycompa® (Perampanel)Provides Sustained Seizure Control for People Living With Refractory Epilepsy

HATFIELD, England, May 29, 2014 /PRNewswire/ --

PRESS  RELEASE  FOR  EU  MEDIA  ONLY:  NOT  FOR  SWISS/U.S  JOURNALISTS 

Data from a large extension study of Fycompa^® (perampanel), published online in the leading clinical journal Epilepsia, demonstrate that the first-in-class epilepsy treatment reduces seizure frequency over sustained periods of time (up to two years of treatment).^[1] Perampanel is indicated for the adjunctive treatment of partial onset seizures, with or without secondarily generalised seizures, in people with epilepsy aged 12 years and older.^[2]

Results from the 307 extension study of 1,218 adolescents and adults (≥12 years) with uncontrolled partial onset seizures, despite treatment with up to three other anti-epileptic drugs (AEDs), show that perampanel provides sustained reductions in seizure frequency over two years*. In patients with at least two years perampanel exposure and secondary generalised seizures at baseline (n=141), an up to 90% reduction in secondary generalised seizures was observed. Among the 694 patients with maintenance data for at least one year, 5.3% were seizure-free for the entire year.^[1]

The study showed that perampanel was well tolerated in patients up to 3.3 years** at a median daily dose of 10.6 mg/day. The most frequent adverse events reported in ≥10% of patients were dizziness, somnolence, headache, fatigue, irritability and weight increase. Only dizziness and irritability caused discontinuation from the study in >1% of patients (3.9% and 1.3%, respectively).^[1]  

Safety and seizure responses were similar across a large number of geographical regions and ethnicities (249 centres in 39 countries), with high treatment retention at the study end (average 58.5%).^[1]

"The 307 study data provide evidence of the sustained seizure control and freedom that long-term perampanel use can provide people with epilepsy, regardless of where they live in the world. They also confirm the safety and tolerability of the therapy as seen in earlier clinical trials, but over longer treatment periods; thereby adding to the growing weight of evidence supporting use of this first-in-class medication," commented Professor Bernhard Steinhoff, from Epilepsiezentrum Kork, Kehl-Kork, Germany.

Perampanel is the only licensed AED to selectively target AMPA receptors, a protein in the brain which plays a critical role in the spread of seizures.^[3] This mechanism of action is different to all other currently available AEDs. Perampanel has the added benefit of convenient, once-daily dosing at bedtime^[2] and, significantly, is the only new-generation partial onset epilepsy treatment approved to treat adolescents from launch.

Discovered and developed by Eisai in Europe and Japan, perampanel is manufactured in the UK and was approved by the European Commission on 23 July 2012. The development of this novel therapy 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.

*After titration/conversion, responder rate and median percentage change from baseline in seizure frequency were stable: 46% for both measures at nine months (in 980 patients with ≥9 months' exposure) and 58% and 60%, respectively, at two years (in the 337 patients with 2 years' exposure).^[1]

**Among 1,216 patients, median duration of exposure to perampanel was 1.5 years (range, 1 week-3.3 years), with >300 patients treated for over two years.^[1]

Notes  to  Editors 

About  Study  307^[1]

The Phase III open-label extension study (n=1,218) of patients from pivotal trials 304^[4], 305^[5], 306^[6] was designed to evaluate safety, tolerability, and seizure outcome data during long-term treatment with once-daily adjunctive perampanel in people with refractory partial onset seizures.

Patients aged ≥12 years with partial-onset seizures despite treatment with one to three antiepileptic drugs at baseline completed a perampanel Phase III trial and entered extension study 307 (NCT00735397). Patients were titrated to 12 mg/day (or their individual maximum tolerated dose) during the blinded conversion period, followed by open-label maintenance. Exposure, safety (adverse events, vital signs, weight, electrocardiography [ECG], laboratory values) and seizure outcomes were analysed; key measures were assessed by geographic regions.

About  Fycompa^® (perampanel) 

Perampanel is indicated for the adjunctive treatment of partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.^[2]

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.^[2]

For more information please visit: http://www.fycompa.eu  

About  Epilepsy  

Epilepsy is one of the most common neurological conditions in the world, affecting approximately eight in 1,000 people in Europe, and an estimated 50 million people worldwide.^[7],[8]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  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^® (perampanel) for the adjunctive treatment for partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older
• Zonegran^® (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 6 years and above. (Zonegran is under license from the originator Dainippon Sumitomo Pharma)
• Zebinix^® (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial onset seizures, with or without secondary generalisation. (Zebinix is under license from BIAL)
• Inovelon^® (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients ≥4 years (Rufinamide was originally developed by Novartis)

About  Eisai  

Eisai is one of the world's leading research and development (R&D) based pharmaceutical companies and 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 human health care (hhc).

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

• Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight management
• Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc.
• Vascular/Immunological reaction including: thrombocytopenia, rheumatoid arthritis, psoriasis, inflammatory bowel disease

With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 10,000 people worldwide. From its EMEA Knowledge Centre in Hatfield, UK, Eisai has recently expanded its business operations to include Europe, the Middle East, Africa, Russia and Oceania (EMEA). Eisai EMEA has sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Czech Republic, Slovakia, the Netherlands, Belgium, Russia and the Middle East.

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

References 

1 Krauss GL et  al. Long-term safety of perampanel and seizure outcomes in refractory partial-onset seizures and secondarily generalised seizures: Results from Phase III extension study 307. Epilepsia 2014; DOI: 10.1111/epi.12643 (available at http://onlinelibrary.wiley.com/doi/10.1111/epi.12643/pdf)
2 Fycompa, Summary of Product Characteristics (Updated November 2013): http://www.medicines.org.uk/emc/medicine/26951/
3 Rogawski MA. Revisiting AMPA receptors as an antiepileptic drug target. Epilepsy Currents 2011;11:56-63
4 French JA. Adjunctive perampanel for refractory partial-onset seizures: randomized phase III study 304. Neurology 2012;79:589-596
5 French JA et al. Evaluation of adjunctive perampanel in patients with refractory partial-onset seizures: Results of randomized global phase III study 305. Epilepsia 2013:54(1):117-125
6 Krauss GM et al. Randomized phase III study 306: Adjunctive perampanel for refractory partial-onset seizures. Neurology 2012;78:1408-1415.
7 Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. http://www.ibe-epilepsy.org/downloads/EURO  Report  160510.pdf [ Last accessed May 2014].
8 Pugliatti M, et al. Estimating the Cost of Epilepsy in Europe: A Review with Economic Modeling. Epilepsia 2007: 48(12): 2224-2233.

Date of preparation: May 2014
Job code: Perampanel-UK2159