New First-in-Class Epilepsy Treatment Fycompa® (Perampanel) Launches in Switzerland PR Newswire HATFIELD, England, March 19, 2013 HATFIELD, England, March 19, 2013 /PRNewswire/ -- Fycompa ^® (perampanel), the first in an entirely new class of treatment for uncontrolled partial-onset seizures (the most common form of epilepsy), launches today in Switzerland. The new therapy is indicated as an adjunctive treatment for partial-onset seizures, with or without secondary generalised seizures, in people with epilepsy aged 12 years and older. ^ Perampanel is the first and only licensed anti-epileptic drug (AED) to selectively target AMPA receptors, a protein in the brain which plays a critical role in causing 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 bedtime ^[ ^1] and, significantly, is the only new-generation partial epilepsy treatment approved to treat adolescents with epilepsy from launch. "Effective seizure management still remains a challenge for up to 30% of people with partial onset seizure despite appropriate therapy. Perampanel offers a new mechanism of action that can potentially help people in Switzerland achieve better seizure control," commented Dr Gunther Kramer, Medical Director, Swiss Epilepsy Centre. "Uncontrolled seizures can severely impact a patient's quality of life and the new treatment will give an additional option to patients to help manage their condition. We welcome this new addition to doctors' epilepsy treatment armamentarium." Epilepsy is one of the most common neurological conditions in the world ^ and an estimated 70,000 people live with epilepsy in Switzerland. ^ The incidence of uncontrolled partial epilepsy remains high despite many new AEDs, and between 20 - 40% of people with newly diagnosed epilepsy will become refractory to treatment. ^ Perampanel's approval by the Swiss agency for the authorisation and supervision of therapeutic products, Swissmedic, was based on three global pivotal Phase III studies with 1,480 subjects. These randomised, double-blind, placebo-controlled and dose-escalated studies showed consistent results in the efficacyand tolerability of perampanel as an adjunctive therapy in people with partial-onset seizures (with or without secondary generalisations). ^,, The most commonly reported adverse events were dizziness, somnolence, fatigue, headache, falls, irritability and ataxia. ^[ ^6] ^, ^[ ^7] ^, ^[ ^8] Perampanel was approved by the European Commission on 23 July 2012, and in Europe the drug is currently available in the UK, Denmark, Germany, Sweden, Norway and Austria. Swissmedic approved perampanel for use in December 2012 and the FDA approved perampanel for use in the US on 22 October 2012. Discovered and developed by Eisai in Europe and Japan, perampanel is going to be manufactured in the UK. The development of perampanel 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 well-being of people worldwide. Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of patients with epilepsy and their families. Eisai is proud to currently market more epilepsy products in Europe, the Middle East, Africa and Russia (EMEA) than any other company. Notes to Editors About Perampanel Perampanel is licensed in Europe Union and Switzerland as an adjunctive treatment for people aged 12 years and older with partial-onset seizures, with or without secondarily generalised seizures. ^[ ^1] 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. ^[ ^1] About the Perampanel pooled data (Study 306, 305 and 304) The pooled Phase III data analysed the efficacy of once-daily perampanel in reducing partial-onset seizures, the most common form of epilepsy, and its effectiveness and flexibility of use as add-on therapy. Efficacy end points for studies 304, 305, and 306 were pooled according to randomised treatment: placebo, perampanel 2, 4, 8 or 12mg. The full ITT (intention-to-treat) analysis set included 1,478 patients from studies 304 (n=387), 306 (n=386) and 306 (n=705). Median reductions in partial seizure frequency were greater with perampanel 4 mg (-23·3%), 8 mg (-28·8%), and 12 mg (-27·2%) than placebo (-12·8%; p<0·01, each dose vs placebo). Median (95% CI) differences from placebo in changes in partial seizure frequency were -12·2% (-20·1 to -4·6), -17·9% (-24·1 to -11·8), and -15·8% (-23·0 to -8·7) for perampanel 4, 8, and 12 mg, respectively. ^[ ^9] Fifty percent responder rates were greater with perampanel 4 mg (28·5%), 8 mg (35·3%), and 12mg (35·0%) than placebo (19·3%; p<0·05, each dose vs placebo). Median reductions in complex partial seizure frequency were greater with perampanel 4 mg (-31·2%), 8 mg (-35·6%), and 12 mg (-28·6%) than placebo (-13·9%). ^[ ^1] Results from two separate analyses of pooled data from the perampanel pivotal Phase III clinical trial programme endorse the efficacy and safety of the new AED at clinically relevant doses. ^ In addition, the results show that perampanel decreased the frequency of both complex partial seizures and secondarily generalised seizures. ^ In a third analysis of the pooled trial data, patients with uncontrolled partial-onset seizures taking any of the five most commonly-used AEDs with perampanel as an add-on therapy experienced a reduction in their seizure frequency. Patients generally received additional benefit from increased doses of perampanel. ^ Perampanel was generally well tolerated; most adverse events were mild/moderate. ^[ ^6] ^, ^[ ^7] ^, ^[ ^8] The clinical development plan for perampanel consisted of three global Phase III studies (studies 306, 305 and 304). The key goal of Study 306 ^[ ^6] was to identify the minimal effective dose and included four treatment arms (placebo, 2mg, 4mg, and 8mg). Study 304 ^[ ^7] and Study 305 ^[ ^8] included three arms (placebo, 8mg, and 12mg) and were to evaluate a more extended dose range. The studies were similar in design: global, randomised, double-blind, placebo-controlled, dose-escalation, parallel-group studies. The primary and secondary endpoints were the same in all the studies: percentage change in seizure frequency, 50% responder rate, percentage reduction of complex partial plus secondarily generalised seizures, and evaluation for dose response. The primary endpoint for the EMA is 50% responder rate and for the FDA is median percent change in seizure frequency. 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 with the condition 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 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 Europe, the Middle East, Africa and Russia (EMEA). In the EMEA region, Eisai currently has four marketed treatments including: *Zonegran ^® (zonisamide) as monotherapy and adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. (Zonegran is under license from the originator Dainippon Sumitomo Pharma). In Switzerland, Zonegran is only approved as adjunctive therapy. *Zebinix ^® (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. (Zebinix is under license from BIAL). Zebinix is not approved by Swissmedic. *Inovelon ^® (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients >4 years *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 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 loss *Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc *Vascular/Immunological reaction including: thrombocytopenia, rheumatoid arthritis, psoriasis, and inflammatory bowel disease With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 11,000 people worldwide. From its Europe based Knowledge Centre in Hatfield, UK, Eisai has recently expanded business operations to include the expanded territory of Europe, the Middle East, Africa and Russia (EMEA). Eisai EMEA 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, Belgium, Luxembourg, the Middle East and Russia. For further information please visit: http://www.eisai.com References: 1. Fycompa. Summary of Product Characteristics. November 2012 2. Rogawski MA. Revisiting AMPA receptors as an antiepileptic drug target. Epilepsy Currents 2011;11:56-63 3. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe 2010. Available at; http://www.ilae.org/Visitors/Documents/ILAEAnnual-Report2010Final_000.pdf (Accessed Feb 2013) 4. EPI Swiss Epilepsy Centre. Available at: http://www.epi.ch/page.php?pages_id=301&language=fr (Accessed Feb 2013) 5. French JA. Refractory Epilepsy; Clinical Overview. Epilepsia 2007: 48 (Suppl1) 3 - 7. 6. Krauss GM. Serratosa JM, Villanueva V et al. Neurology 2012: Available at: http://www.neurology.org/ [ http://www.neurology.org ] 7. French JA. Adjunctive perampanel for refractory partial-onset seizures: randomized phase III study 304. Neurology 2012;79:589-596 8. French JA et al. Evaluation of adjunctive perampanel in patients with refractory partial-onset seizures: Results of randomized global phase III study 305. Epilepsia 2012:1-9. In press online 9. Ben-Menachem E,Krauss GL, Noachtar S et al. Abstract presented at ECE 2012 10. Steinhoff BJ, Gauffin H, McKee P et al. Abstract presented at ECE 2012 11. Trinka E, Straub H, Squillacote D et al. Abstract presented at ECE 2012 12. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [Accessed August 2012] 13. Pugliatti M, et al. Epilepsia Estimating the cost of epilepsy in Europe: a review with economic modelling. 2007: 48(12);2224–2233 Date of preparation: March 2013 Fycompa-EU0022 Contact: Eisai Europe Ltd: Cressida Robson / Charlotte Andrews, +44(0)7908-314-155, +44(0)7947-231-513, Cressida_Robson@eisai.net, Charlotte_Andrews@eisai.net ; Tonic Life Communications, Hollie Matthews, +44 (0)20-7798-9992, firstname.lastname@example.org
New First-in-Class Epilepsy Treatment Fycompa® (Perampanel) Launches in Switzerland
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