Data from a three-year safety study of Fycompa(R) (perampanel), published online in leading clinical journal Epilepsia, demonstrate that the first-in-class epilepsy treatment controls and reduces seizures over sustained periods of time (up to three years). 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.
Results from the 307 extension study of 1,216 adolescents and adults (greater than or equal to12 years) with partial onset seizures, despite previous treatment with greater than or equal to3 anti-epileptic drugs (AEDs), show that perampanel provides stable reductions in seizure frequency over treatment periods of up to three years*. Up to 90% of patients achieved a reduction in secondarily generalised seizures and 5% of patients achieved seizure freedom lasting at least one year.
The study showed that perampanel was well tolerated for up to three years of treatment** at a median daily dose of 10.6 mg/day. The most frequent AEs which were reported in greater than or equal to10% of patients were dizziness, somnolence, headache, fatigue, irritability and weight increase. Only dizziness and irritability caused discontinuation of the study in >1% of patients (3.9% and 1.3%, respectively).
Safety and seizure responses were similar across a large number of geographical regions and ethnicities, with high treatment retention consistent throughout (averaging 58.5%).
"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 therapyas 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. This mechanism of action is different to other currently available AEDs. Perampanel also has the added benefit of convenient, once-daily dosing at bedtime. Plus, it is the only new-generation partial 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.
About Study 307
The Phase III extension study (n=1,218) of patients from pivotal trials 304, 305, 306 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 greater than or equal to 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 12mg/day (or their individual maximum tolerated dose) during the blinded conversion period, followed by open-label maintenance. Exposure, safety (adverse events, vital signs, weight, ECG, laboratory values) and seizure outcomes were analysed; key measures were assessed by geographic regions.
Fycompa 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.
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.
For more information please visit: http://www.fycompa.eu