Data at the International Epilepsy Congress in Istanbul show Fycompa® (perampanel) treatment may significantly reduce seizure frequency, both in patients with primary generalised tonic-clonic (PGTC) seizures (seizure frequency was reduced 62.3% versus 31.7% placebo shown in a subset analysis of a recently published phase 3 study (332) in patients having PGTC seizures with idiopathic generalised epilepsy), and partial epilepsy (8.6% of patients were seizure free at six months shown in a retrospective analysis of Spanish data of 315 patients with partial-onset seizures).1, 2
For patients with PGTC seizures, an up-titration of perampanel over 4 weeks may reduce the number of PGTC seizures experienced by 62.3% versus placebo (31.7%), and higher perampanel exposure was associated with a greater probability of response.1The double-blind phase III study used pharmacodynamic modelling to describe and predict relationships between perampanel exposure and seizure outcomes in a typical male without concomitant enzyme-inducing anti-epileptic drugs.1
In a second study examining patients with partial-onset seizures, data shows perampanel increases response and retention rates when used as an adjunctive treatment.2 In an interim update from a real-life study of 315 patients with partial onset seizures (POS) in Spain, at six months the retention rate was high at 79.4%, 8.6% of patients were seizure-free and 32.9% responded to treatment.2 Perampanel further reduced the frequency of secondary generalised seizures from 27.2% to 17.6%, and had significant effects in patients 65 or older and in patients that had tried five or more anti-epileptic drugs in this study.2
"These results illustrate that perampanel's novel mechanism of action yields an excellent response in terms of seizure frequency, when used adjunctively with existing anti-seizure therapies, across the most common seizure types," comments Eugen Trinka, Chair of the Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University, Salzburg.
An independent group review eliminated 29.9% of patients, initially considered eligible, from inclusion in perampanel's recently published Study 332, to ensure appropriate classification of participants.3 This was the first PGTC seizure study to use external review.3
Perampanel, an oral treatment with a simple titration regimen, is currently indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients from 12 years of age with epilepsy, and as adjunctive therapy for the treatment of primary generalised tonic-clonic seizures in patients aged 12 years and older with idioipathic generalised epilepsy.4 Perampanel is the only licensed anti-epileptic drug to selectively target AMPA receptors, a protein in the brain which plays a critical role in the spread of seizures.5This mechanism of action is different to other, currently available anti-epileptic drugs.
A further sub-group analysis of another phase III trial, showed that Inovelon® (rufinamide) demonstrates favourable efficacy as adjunctive treatment for adults with Lennox-Gastaut syndrome.6 Median change from baseline in seizure frequency was -31.5% for rufinamide (n=21)_versus +22.1% for placebo (n=10).6
"Since Lennox-Gastaut syndrome often persists into adulthood, or may have late onset in adulthood, these data are promising and show that rufinamide is efficacious compared with placebo when used adjunctively", comments Pasquale Striano, University of Genoa, G. Gaslini Institute.
Rufinamide is currently indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in children four years and older.7 Lennox-Gastaut Syndrome is a severe, rare form of childhood-onset epilepsy, which affects nearly 208,000 people in Europe.8 Effective Lennox-Gastaut Syndrome management and compliance to treatment is of key importance to patients as the condition is characterised by a high number of seizures, people may experience up to 70 seizures a day.9 The condition often persists into adulthood and most people with this type of epilepsy will have developmental delay, mental retardation, and moderate to severe learning disabilities, in addition to, physiological and behavioural problems.10, 11
The development of perampanel and rufinamide demonstrates Eisai's commitment in the therapeutic area of epilepsy and further exemplifies the company's contribution to addressing the diversified needs of and increasing the benefits provided to patients and their families as shown by its human health care mission.