This is a summary of the European public assessment report (EPAR) for Fycompa. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Fycompa
- What is Fycompa?
Fycompa is a medicine that contains the active substance perampanel. It is available as tablets (2, 4, 6, 8, 10 and 12 mg).
- What is Fycompa used for?
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 must only be used as an ‘add-on’ therapy to other anti-epileptic medicines.
The medicine can only be obtained with a prescription.
- How is Fycompa used?
Fycompa is taken by mouth once a day before bedtime. The tablet should be swallowed whole and should not be chewed, crushed or split. The recommended dose at the start of treatment is 2 mg per day, and if it is well tolerated the doctor may progressively increase it by increments of 2 mg per day to a maximum dose of 12 mg per day. The dose should not exceed 8 mg per day in patients with mildly or moderately reduced liver function.
- How does Fycompa work?
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. Therefore by blocking glutamate’s actions, Fycompa is thought to stop epileptic seizures from occurring.
- How has Fycompa been studied?
The effects of Fycompa were first tested in experimental models before being studied in humans.
Fycompa has been compared with placebo (a dummy treatment) in three main studies involving a total of 1,491 patients aged 12 years and older with partial-onset seizures who did not respond to other treatments. In these studies, Fycompa was given at a dose of 2, 4, 8 or 12 mg per day for up to 19 weeks. All patients were also taking other anti-epileptic medicines. The main measure of effectiveness was the percentage of patients who experienced at least a 50% decrease in seizure frequency.
- What benefit has Fycompa shown during the studies?
Fycompa at doses from 4 mg to 12 mg was shown to be more effective than placebo in reducing the frequency of epileptic seizures. In the first study, the percentage of patients who experienced a decrease in seizure frequency of at least 50% was 37.6% for patients taking 8 mg Fycompa and 36.1% for patients taking 12 mg Fycompa, compared with 26.4% of patients taking placebo. In the second study, 33.3% and 33.9% of patients taking 8 mg and 12 mg Fycompa respectively showed a decrease in seizure frequency of at least 50%, compared with 14.7% of patients taking placebo. The third study showed a significant decrease in seizure frequency only in patients taking 4 mg and 8 mg Fycompa but not in patients taking a dose of 2 mg.
- What is the risk associated with Fycompa?
The most-common side effects with Fycompa (seen in more than 1 patient in 10) are dizziness and somnolence (sleepiness). For the full list of all side effects reported with Fycompa, see the package leaflet.
Fycompa must not be used in people who are hypersensitive (allergic) to perampanel or any of the other ingredients.
- Why has Fycompa been approved?
The CHMP considered that Fycompa, taken together with other anti-epileptic medicines, showed a consistent reduction in the frequency of epileptic fits and that no serious toxicity has been identified. Therefore, the CHMP decided that Fycompa’s benefits are greater than its risks and recommended that it be given marketing authorisation.
- Other information about Fycompa
The European Commission granted a marketing authorisation valid throughout the European Union for Fycompa on 23 July 2012.
For more information about treatment with Fycompa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This EPAR was last updated on 27/11/2012 .
14/11/2012 Fycompa -EMEA/H/C/002434 -IB/0004
|Name||Language||First published||Last updated|
|Fycompa : EPAR - Product Information||BG = bălgarski||07/08/2012||27/11/2012|
|Fycompa : EPAR - Product Information||ES = español||07/08/2012||27/11/2012|
|Fycompa : EPAR - Product Information||CS = čeština||07/08/2012||27/11/2012|
|Fycompa : EPAR - Product Information||DA = dansk||07/08/2012||27/11/2012|
|Fycompa : EPAR - Product Information||DE = Deutsch||07/08/2012||27/11/2012|
|Fycompa : EPAR - Product Information||ET = eesti keel||07/08/2012||27/11/2012|
|Fycompa : EPAR - Product Information||EL = elliniká||07/08/2012||27/11/2012|
|Fycompa : EPAR - Product Information||EN = English||07/08/2012||27/11/2012|
|Fycompa : EPAR - Product Information||FR = français||07/08/2012||27/11/2012|
|Fycompa : EPAR - Product Information||IT = italiano||07/08/2012||27/11/2012|
|Fycompa : EPAR - Product Information||LV = latviešu valoda||07/08/2012||27/11/2012|
|Fycompa : EPAR - Product Information||LT = lietuvių kalba||07/08/2012||27/11/2012|
|Fycompa : EPAR - Product Information||HU = magyar||07/08/2012||27/11/2012|
|Fycompa : EPAR - Product Information||MT = Malti||07/08/2012||27/11/2012|
|Fycompa : EPAR - Product Information||NL = Nederlands||07/08/2012||27/11/2012|
|Fycompa : EPAR - Product Information||PL = polski||07/08/2012||27/11/2012|
|Fycompa : EPAR - Product Information||PT = português||07/08/2012||27/11/2012|
|Fycompa : EPAR - Product Information||RO = română||07/08/2012||27/11/2012|
|Fycompa : EPAR - Product Information||SK = slovenčina||07/08/2012||27/11/2012|
|Fycompa : EPAR - Product Information||SL = slovenščina||07/08/2012||27/11/2012|
|Fycompa : EPAR - Product Information||FI = suomi||07/08/2012||27/11/2012|
|Fycompa : EPAR - Product Information||SV = svenska||07/08/2012||27/11/2012|
|Fycompa : EPAR - Product Information||IS = Islenska||07/08/2012||27/11/2012|
|Fycompa : EPAR - Product Information||NO = Norsk||07/08/2012||27/11/2012|
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Anti-epileptics, other anti-epileptics
Treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older.
Changes since initial authorisation of medicine
|Name||Language||First published||Last updated|
|Fycompa : EPAR - Procedural steps taken and scientific information after authorisation||(English only)||17/10/2012||27/11/2012|
Initial marketing-authorisation documents
This medicine is approved for use in the European Union