HATFIELD, England, May 27, 2015 /PRNewswire/ --
Phase III study demonstrates significant improvements in seizure freedom and seizure reduction in people living with this severe type of epilepsy
Fycompa® (perampanel) today received positive opinion for use as a once-daily, adjunctive therapy for primary generalised tonic-clonic seizures in adult and adolescent patients from 12 years of age with idiopathic generalised epilepsy from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).
In the first randomised, Phase III, double-blind, placebo-controlled trial to evaluate the efficacy and safety of adjunctive perampanel for the treatment of primary generalised tonic-clonic (PGTC) seizures in patients aged ≥12 years with idiopathic generalised epilepsy, 164 patients were randomised and included 81 patients who received perampanel and 81 patients who received placebo. Results show that reduction in PGTC seizure frequency was greater in patients receiving perampanel compared with placebo (76.5% vs 38.4%, respectively; P<0.0001). The 50% responder rate for patients with PGTC seizures was also greater with perampanel than placebo (64.2% vs 39.5%, respectively; P=0.0019. Both of these are our primary endpoints. Furthermore, 31% of patients were seizure free during the 13-week maintenance period when treated with perampanel as an adjunctive therapy, compared to 12% in the placebo group. Patients treated with perampanel also experienced improved quality of life across all domains measured, including daily activities, cognition and distress.
Perampanel is currently indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older. Perampanel is the only licensed anti-epileptic drug (AED) to selectively target AMPA receptors, a protein in the brain which plays a critical role in the spread of seizures. This mechanism of action is different to other, currently available AEDs. In addition, perampanel has the added benefit of convenient, once-daily dosing at bed time.
"Primary generalised tonic-clonic seizures are a severe type of epilepsy that can have a serious impact on a person's quality of life. These data highlight significant seizure reduction, improved seizure freedom rates and measurable improvements in quality of life amongst people who were refractory to treatment," comments Professor Eugen Trinka, Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University, Salzburg, Austria.
Generalised tonic-clonic seizures can be a dangerous type of epilepsy. The seizures start with a loss of consciousness and a sudden contraction of the muscles, which can cause the person to fall down (tonic phase). This is followed by violent convulsions (clonic phase) until the muscles finally relax. Between 20%-40% of people with newly diagnosed epilepsy are, or become refractory to treatment, resulting in a potential negative impact on quality of life.
Perampanel was investigated in PGTC in study 332, a double-blind, randomised, placebo-controlled, multicentre, parallel-group trial to evaluate the efficacy and safety of adjunctive perampanel for refractory tonic-clonic seizures in patients with idiopathic generalised epilepsy. Results demonstrate that perampanel significantly reduces the number of PGTC seizures, the study's primary outcome measure, when compared to placebo. Perampanel was generally well tolerated, the most frequent adverse events (10% in the perampanel arm and greater than placebo) were dizziness, fatigue and headache, irritability and somnolence. The adverse event profile in this study is similar to that for other perampanel studies.
"As a research-based pharmaceutical company with a strong portfolio of epilepsy products, we are committed to bring innovative new therapies to market and maximise the clinical benefits of our currently licensed products. If approved in Europe as a treatment for people with idiopathic generalised epilepsy, perampanel will offer an important new treatment option to help improve the lives of people with this dangerous type of epilepsy," comments Neil West, Head of Epilepsy Business Unit, Eisai EMEA.
The continued 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 needs of patients with epilepsy and their families. Eisai is proud to market more epilepsy products in EMEA than any other company.
Notes to Editors
About Fycompa® (perampanel)
Perampanel is currently indicated for the adjunctive treatment of primary generalised tonic-clonic seizures in adult and adolescent patients from 12 years of age with idiopathic generalised 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.
Since launch Perampanel has helped treat 33,496 people living with epilepsy across Europe.
Further information can be found at http://www.fycompa.eu
About Study 332
This Phase III, double-blind, randomised, placebo-controlled, multicentre, parallel-group trial evaluates the efficacy and safety of adjunctive perampanel for refractory tonic-clonic seizures, compared to placebo, amongst 164 patients aged 12 years and older with PGTC seizures receiving one to maximum of three anti-epileptic drugs. The study was conducted across centres in the U.S., Europe, Japan and Asia.
Perampanel was administered via oral tablets, once daily, up to 8 mg/day (titration phase) and then maintained on maximum tolerated dose (maintenance phase). The study period was divided into the pre-randomisation phase (screening and baseline periods): up to 12 weeks, the randomisation phase (treatment): 17 weeks (titration phase, 4 weeks; maintenance phase, 13 weeks) followed by an extension phase.
Results demonstrate that perampanel significantly reduces the number of PGTC seizures (≥50% reduction in seizure frequency per 28 days in the maintenance period, relative to baseline), the study's primary outcome measure, when compared to placebo. Perampanel was generally well tolerated, the most frequent adverse events (10% in the perampanel arm and greater than placebo) were dizziness, fatigue and headache, irritability and somnolence. The adverse event profile in this study is similar to that for other perampanel studies.
About Primary Generalised Tonic-Clonic Seizures
For the majority of patients, a primary generalised tonic-clonic (PGTC) seizure begins with or without an aura which is followed by rigid muscle. This leads to violent muscle contraction (clonic phase) and a loss of consciousness. 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.
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. 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 the development and delivery of 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 use as an adjunctive treatment for partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older
- Inovelon® (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients >4 years. (Rufinamide was originally developed by Novartis)
- 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 generalisation, in adults, adolescents and children aged six 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).
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.
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Date of preparation: May 2015
Job code: Perampanel-UK2190