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New data presented from registry study for Inovelon® (rufinamide) for people with Lennox-Gastaut Syndrome
New data presented today at the 12th European Congress on Epileptology (ECE) of an open-label extension study of the pivotal Phase III randomised, double-blind, placebo-controlled, clinical Study 332, showed that long-term adjunctive perampanel for up to two and a half years (142 weeks) provided sustained seizure control and was generally well tolerated in poorly controlled patients with primary generalised tonic clonic (PGTC) seizures, in idiopathic generalised epilepsy (IGE).
Perampanel is indicated in the European Union for adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures, and for adjunctive treatment of PGTC seizures in patients with IGE aged 12 years and older.
In the open-label extension study, 138 patients received once-daily adjunctive perampanel for up to 136 weeks following dose-optimisation in a 6-week blinded conversion period. Sixty patients discontinued perampanel during the extension study, most (n=41) due to reasons other than adverse events or inadequate therapeutic response. By the end of the conversion period, results were as follows:
Seizure Measure N=138 Perampanel (n=68) Placebo (n=70) Median per cent change in PGTC seizure frequency -93.1% -100% 50% responder rates 75.0% 74.3%
Treatment-emergent adverse events were seen in 120 patients (87.0%) with 20 patients (14.5%) having severe adverse events, 18 (13.0%) with serious adverse events, and 13 (9.4%) with adverse events leading to withdrawal.
"The extension study shows that patients with primary generalised tonic clonic seizures in idiopathic generalised epilepsy achieve similar clinical benefits, with consistent tolerability, to those seen previously in Study 332," comments Eugen Trinka, Professor and Chair of the Department of Neurology, Paracelsus Medical University, Salzburg, Austria.
Exploratory outcomes from a post-hoc analysis of the 17-week core phase of Study 332 showed that compared with placebo, adjunctive perampanel showed no clear evidence for worsening of myoclonic or absence seizures. There was a difference in baseline seizure frequency for myoclonic and absence seizures between perampanel and placebo groups and the study was not powered to detect differences in these seizure types.
(n=162) Seizure Type Perampanel (n=81) Placebo (n=81) Baseline myoclonic 29.0% Baseline absence 37.0% Perampanel Placebo Absence seizure freedom 22.2% 12.1% Absence seizure worsening 29.6% 45.5% Myoclonic seizure freedom 16.7% 13.0% Myoclonic seizure worsening 29.2% 30.4%
The most common adverse events with perampanel in the 17-week core phase of Study 332 were dizziness, fatigue, headache, somnolence and irritability.
Data from open-label extension Study 307 in patients with focal epilepsy treated with adjunctive perampanel for up to four years were also presented, including seizure outcomes:
Change during last year of 3 Years Perampanel 4 Years Perampanel perampanel treatment Exposure (n=436) Exposure (n=78) Median % seizure reduction 61.98% 70.63% Median % seizure reduction in secondarily generalised seizures 87.96% 100% 50% responder rate 59.6% 67.9% No new safety signals were seen during long-term perampanel exposure
Final results from a European patient registry study for safety in 111 patients of all ages (>=4 years) with Lennox-Gastaut Syndrome (LGS), suggest the potential for rufinamide and 'other' antiepileptic drugs in the long-term treatment of LGS. At Month 12, the proportion of patients rated as 'much', or 'very much' improved in control of all seizures was 12/42 (28.6%) and 5/33 (15.2%) for rufinamide and other AEDs, respectively.
Treatment-related adverse events were reported for 40.6% for rufinamide and 27.7% for other AEDs patients, and led to discontinuation of 7.8% and 2.1% of patients, respectively. The most frequently reported rufinamide-related adverse events (>=5% patients) were somnolence (7.8%) and decreased appetite (6.3%). There were no unexpected safety findings.
Rufinamide is indicated in the European Union as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut Syndrome in patients four years of age and older.
There are limited published data on the treatment of adults with Lennox-Gastaut Syndrome. In another analysis of this study, data on adults (>=18 years) were extracted and analysed. Twenty-four adult patients were included (16 on rufinamide and 8 on another antiepileptic drug).
At Month 24, the proportion of patients rated as 'much' or 'very much' improved in control of all seizures was 2/7 (28.6%) and 2/4 (50.0%) for rufinamide and other AEDs, respectively. AED-related adverse events were reported for 50.0% for rufinamide and 37.5% for other AEDs patients, and led to discontinuation of 6.3% and 0% of patients, respectively. The only rufinamide-related adverse event reported for more than one adult was somnolence (n=2). There were no unexpected safety findings.
The registry enrolled patients with Lennox-Gastaut Syndrome (age >=4 years) requiring modification to any anti-epileptic treatment, including initiation of rufinamide. The primary objective of the registry was to evaluate long-term safety., Seizure control was also assessed using a 7-point generic seizure frequency scale (rated from 'very much worse' to 'very much improved'). A total of 111 patients were enrolled and included in the safety analysis set, of whom 64 initiated rufinamide and 47 were initially allocated other antiepileptic drugs. For the analysis of the adult population from this safety analysis set, 24 patients were included (16 on rufinamide and 8 on another antiepileptic drug).
"The data presented for perampanel and rufinamide provide new insights into the long-term care of people with epilepsy. There is no known cure and people have to live with the consequence of epilepsy day in and day out. Eisai is committed to understanding the long-term impact of its treatments, for seizure freedom and safety, and these results help us to enhance our knowledge of treatment in everyday life," comments Neil West, Vice President, Global Neurology Business Group, Eisai EMEA.
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 neurology 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, approximately 52,000 people living with epilepsy across the EMEA region* have been treated with perampanel.
*EMEA countries are Germany, Italy, United Kingdom, Spain, France, Switzerland, Netherlands, Ireland, Sweden, Norway, Denmark, Austria, Belgium, Czech Republic, Portugal, Greece, Australia, Russia, Slovakia, Israel.
Clinical data for Fycompa® (perampanel) - Phase III study 332
Study 332 is a double-blind, randomised, placebo-controlled, multicentre, parallel-group trial to evaluate the efficacy and safety of adjunctive perampanel for refractory primary generalised tonic clonic (PGTC) seizures in idiopathic generalised epilepsy (IGE). 164 people (>=12 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® (rufinamide)
Rufinamide was approved for adjunctive therapy for Lennox-Gastaut Syndrome in Europe (under the brand name Inovelon®) in 2007. Rufinamide 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 is available in Austria, Denmark, France, Finland, Germany, Netherland, Norway, Portugal, Spain, Switzerland, Sweden and the United Kingdom.
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. 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.
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 contractions (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., PGTC seizures can also result in risk of injury and sudden unexpected death in epilepsy (SUDEP).
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) is indicated for use as a once-daily, adjunctive therapy for both primary generalised tonic clonic seizures in idiopathic generalisation and for partial onset seizures, with or without secondary generalisation, in patients with epilepsy aged 12 years or older - Inovelon® (rufinamide) is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients >=4 years. (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 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® (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
1. 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 #555
2. Fycompa® (perampanel) Summary of Product Characteristics (last updated March 2016). Available at: http://www.medicines.org.uk/emc/medicine/26951. Accessed September 2016
3. 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
4. French J, et al. Perampanel for tonic clonic seizures in idiopathic generalised epilepsy. Neurology 2015;85 (11):950-57
5. 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
6. 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 #590
7. Inovelon® (rufinamide) SPC - Inovelon Tablets and Oral Suspension. Available at: http://www.medicines.org.uk/emc/medicine/20165/SPC/ [updated 6 August 2013]. Accessed September 2016
8. Brandt C, et al. Use of rufinamide and other antiepileptic drugs in the management of adult patients (>=18 years) with Lennox-Gastaut Syndrome; European Congress on Epileptology 2016: Abstract #P622
9. Eisai. Data on File 2016. DOF PER112
10. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf. Accessed September 2016
11. Epilepsy Foundation. Types of Seizures. Available at: http://www.epilepsy.com/learn/types-seizures. Accessed September 2016
12. Epilepsy Foundation. IGE Summary. Available at: http://www.epilepsy.com/information/professionals/about-epilepsy-seizures/idiopathic-generalized-epilepsies/idiopathic. Accessed September 2016
13. Smithson WH, et al. Sudden Unexpected Death in Epilepsy: Addressing the Challenges. Curr Neurol Neurosci Rep 2014; 14(12):502
September 2016 Fycompa-EU0180
Cressida Robson / Chloe Fox
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Cressida_Robson@eisai.net / Chloe_Fox@eisai.net. Tonic Life
Communications: Carys Thomas Ampofo / Chris Caudle
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Carys.Thomas-Ampofo@toniclc.com / Chris.Caudle@toniclc.com