The Scottish Medicines Consortium (SMC) have approved Eisai's medicine containing perampanel, brand name Fycompa, for the adjunctive (in addition to other medicines) treatment of partial-onset seizures with or without secondarily generalised seizures in adult and adolescent patients from 12 years of age with epilepsy.
Fycompa is to be used as a second-line adjunctive treatment in patients with refractory partial onset epilepsy who are unable to swallow perampanel tablets. Treatment should be initiated only by physicians who have appropriate experience in the treatment of epilepsy.
The SMC has previously accepted perampanel tablets for restricted use as adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older.
The oral suspension provides an alternative formulation for patients who have difficulty swallowing tablets. Depending on the dose, it may be more expensive than the tablets but any overall net budget impact is likely to be small.
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About Fycompa (source EMA)
Fycompa is used to treat adults and children from 12 years of age with partial-onset seizures (epileptic fits) with or without secondary generalisation. This is a type of epilepsy where too much electrical activity in one part of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness or a sudden sense of fear. Secondary generalisation occurs when the excessive electrical activity subsequently reaches the whole brain.
Fycompa is also used in patients from 12 years of age to treat primary generalised tonic-clonic seizures (major fits or convulsions, where the person becomes unconscious, falls down if standing, and jerks or shakes) associated with idiopathic generalised epilepsy (epilepsy with no apparent cause that is thought to have a genetic origin and that affects the whole brain).
Fycompa must only be used as an ‘add-on’ therapy to other anti-epileptic medicines.
The medicine can only be obtained with a prescription.
The active substance in Fycompa, perampanel, is an anti-epileptic medicine. Epilepsy is caused by excessive electrical activity in the brain. Although the precise mechanism by which Fycompa works is not fully understood, it is thought to block the action of the neurotransmitter glutamate. Neurotransmitters are naturally-occurring chemicals in the nervous system that allow nerve cells to communicate with each other. Glutamate is the main stimulatory neurotransmitter in nerve cells which can trigger and maintain seizures. Therefore by blocking glutamate’s actions, Fycompa is thought to stop epileptic seizures from occurring.
Fycompa was first made available in the EU in 2012. It is manufactured by Eisai.
European Medicines Agency website page for Fycompa
Links available in External Resources
SMC information on Fycompa
Reporting of suspected adverse reactions
Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.
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