HATFIELD, England, May 15, 2014 /PRNewswire/ --
Data from a three-year safety study of Fycompa (perampanel), published online today 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).[1] 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]
Results from the 307 extension study of 1,216 adolescents and adults (12 years) with partial onset seizures, despite previous treatment with 3 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.[1]
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 10% 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).[1]
Safety and seizure responses were similar across a large number of geographical regions and ethnicities, with high treatment retention consistent throughout (averaging 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 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.[3] This mechanism of action is different to other currently available AEDs. Perampanel also has the added benefit of convenient, once-daily dosing at bedtime.[2] 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.
*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 1216 patients, median exposure was 1.5 years (range, 1 week-3.3 years), with >300 patients treated for over two years.[1]
Original post:
Study Shows Fycompa (perampanel) Provides Sustained Seizure Control for People Living With Epilepsy