People with these hard-to-control seizures often fall resulting in potential physical injuries. Frequent generalised tonic clonic seizures can also increase a person's risk of Sudden Unexpected Death in Epilepsy (SUDEP.
Until recently there have been limited numbers of medications licensed for these types of seizures. But now the European Commission has granted marketing authorisation approval for perampanel, for use as an add-on therapy for generalised tonic clonic seizures. This is for both adults and adolescents over the age of 12 with idiopathic generalised epilepsy.
New treatment options
Professor Ley Sander, medical director at Epilepsy Society welcomed the news. 'Any new treatment that offers options for people with uncontrolled seizures has to be good news,' he said.
'Uncontrolled seizures can have a huge impact on a person's quality of life. For young people this can affect their education, social life and self confidence. For adults with continuing seizures it can mean not being able to drive and can often affect employment prospects which in turn can have a negative impact on family life.
'We desperately need new treatments that will offer greater hope.'
Perampanel has been developed by Eisai, a global research and development pharmaceutical company based in Japan. The drug is the only licensed anti-epileptic medication targeting AMPA receptors thought to be involved in the initiation of seizures. Clinical data for the efficacy and safety of the drug used as an add-on therapy for people with uncontrolled generalised tonic clonic seizures, was presented at the first European Academy of Neurology in Berlin.
Perampanel trial results
Results from a randomised controlled trial involving 162 patients showed:
• 30.9 per cent of people taking perampanel during the 13 weeks of the trial on a stable dose were free of GTC seizures compared with 12.3 per cent of people taking a a placebo
• There was a greater reduction in generalised tonic clonic seizures in those taking perampanel (76.5 per cent) compared to those who took placebo (38.4 per cent)
• People treated with perampanel had an improved quality of life compared to those on placebo.
A separate study also assessed the effects of adjunctive perampanel on absence and myoclonic seizures in people with generalised tonic clonic seizures and it suggests that myoclonic seizures were not aggravated by perampanel, while absence seizures were improved.
The most commonly reported adverse effects from perampanel were dizziness, fatigue, somnolence and irritability.