Real world data for Fycompa (perampanel) have been published in 10 abstracts in Epilepsia and will be presented for the first time this week at the XXI European Congress on Epileptology (ECE) in Stockholm, Sweden. In addition, subset data from the Phase III pivotal trials of perampanel will be unveiled at the congress. 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.[1]
The 10 Eisai-supported observational studies evaluate real world experience with adjunctive perampanel in over 350 refractory patients across sites in the UK and Austria.[2]-[11] The data show perampanel as generally effective and well tolerated in a variety of patient populations, including those with highly refractory epilepsy and those with a high number of comorbidities.
In two further abstracts, metabolic parameters were assessed for the perampanel pooled Phase III global pivotal studies (n=1,480)[12] and an open-label extension study (n=1,186).[13] Results show that lipid parameters (blood cholesterol and triglyceride levels) and glucose levels remain stable over time across a range of doses (up to 12mg per day) of perampanel. The most common metabolic treatment emergent adverse event reported for both studies was weight increase.[12],[13]
A study that assessed the impact of perampanel on behaviour in adolescents with refractory partial onset seizures (12-17 years old, n=133) is the subject of an additional abstract at ECE.[14]
"Data such as these add to the growing weight of evidence that supports the use of perampanel for adults and adolescents with refractory epilepsy. Treatments, such as perampanel, that have proven efficacy and an entirely different mode of action compared to other anti-epileptic drugs are an important adjunctive therapy option," commented Christoph Baumgartner, Neurological Center Rosenhuegel and General Hospital Hietzing, Vienna.
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.[15] Perampanel has the added benefit of convenient, once-daily dosing at bedtime[1] and, significantly, is the only new-generation partial onset epilepsy treatment approved to treat adolescents (>12 years) from launch.
The data presented at ECE underscore Eisai's human health care (hhc) mission; the company's commitment to provide innovative solutions in disease prevention, cure and care for the health and wellbeing of people worldwide. Eisai is proud to currently market more epilepsy products in EMEA than any other company.
Notes to Editors
About Fycompa(perampanel)
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.[1]
See the article here:
Real World Data to be Presented for Fycompa (Perampanel) at the European Congress on Epileptology (ECE) 2014