New once-day pill heralds advance in targeted epilepsy treatment

Epilepsy is one of the most common neurological disorders which affects the brain and causes a person to experience repeated seizures. However a brand new drug offers hope to the 600,000 people living with epilepsy in the UK. Discovered and developed by Japanese pharmaceutical company Eisai in their world-class Research & Development facilities in Hertfordshire, parampanel is the first in a new class of treatment for the most common form of the disease, uncontrolled partial epilepsy and is the first and only licensed anti-epileptic drug (AED) to selectively target AMPA receptors, a receptor in the brain which plays a critical role in the spread of epileptic seizures.

This mechanism of action is different to AEDs currently available. In addition, perampanel has the added benefit of convenient, once-daily dosing at bedtime which means it could improve patient compliance. Significantly, it is the only new-generation partial epilepsy treatment approved to treat adolescents and adults with epilepsy from launch.

Fycompa® (perampanel), the first in an entirely new class of treatment for uncontrolled partial onset of seizures (the most common form of epilepsy), is now licensed for use in the UK following approval by the European Commission (EC).

The new therapy has demonstrated efficacy in partial onset seizures with secondarily generalisations seizures, and is indicated as an add on treatment for partial-onset seizures, with or without secondarily generalised seizures, in people with epilepsy aged 12 years and older.

There are over 600,000 individuals in the UK with epilepsy, and 469,000 in England. Improved epilepsy care is crucial as there are around 1000 epilepsy-related deaths each year in the UK, most of which are associated with seizures. Just over a third of these deaths are young adults and children and of the total number of deaths, about 400 per year, are thought to be avoidable.

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 the spread of epileptic seizures. This mechanism of action is different to AEDs currently available. In addition, perampanel has the added benefit of convenient, once-daily dosing at bedtime and, significantly, is the only new-generation partial epilepsy treatment approved to treat adolescents and adults with epilepsy from launch.

Perampanel’s approval by the European Commission (EC) 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 efficacy and 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.

Key information:

• The worldwide supply of the once-daily oral therapy will be manufactured, packaged and distributed from the company’s new £100 million facility in Hatfield, Hertfordshire.
• Although up to 70% of people with epilepsy have the potential to be seizure-free through accurate diagnosis and optimal treatment, according to the Joint Epilepsy Council, this is achieved in only around half of all patients.