What is Fycompa?
Fycompa is a medicine that contains the active substance perampanel. It is available in tablets (2, 4, 6, 8, 10 and 12 mg).
What is Fycompa used for?
Fycompa is used in adults and children aged 12 years and older to treat partial seizures (seizures) with or without secondary generalization. It is a type of epilepsy in which excessive electrical activity in one part of the brain causes symptoms such as sudden spasmodic movements of one part of the body, impaired hearing, smell or vision, numbness or sudden feelings of fear. Secondary generalization is occurs when excessive electrical activity subsequently reaches the entire brain. Fycompa should only be used as an adjunct to other antiepileptic medicines.
The medicine can only be obtained with a prescription.
How is Fycompa used?
Fycompa is taken orally once a day, at bedtime. The tablet should not be chewed, crushed or split, but should be swallowed whole. The recommended dose at the start of treatment is 2 mg per day. If well tolerated, the dose can be progressively increased by the doctor in increments of 2 mg per day up to a maximum of 12 mg per day. The dose should not exceed 8 mg per day in patients with mildly or moderately impaired 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. The exact mechanism of Fycompa's action has not been fully understood, however it is believed to block the action of a neurotransmitter, glutamate. Neurotransmitters are chemicals naturally present in the nervous system that allow nerve cells to communicate with each other. Glutamate is the main stimulating neurotransmitter of nerve cells. Fycompa blocks the action of glutamate and for this reason it is believed to prevent the occurrence of epileptic seizures.
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 from 12 years of age with partial seizures who were not responding 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 in whom there was at least a 50% decrease in seizure frequency.
What benefit has Fycompa shown during the studies?
At doses of 4 mg to 12 mg, Fycompa was more effective than placebo in reducing the frequency of seizures. In the first study, there was a minimum 50% decrease in seizure frequency in 37.6% of patients treated with Fycompa at 8 mg and 36.1% of patients treated with Fycompa at 12 mg, compared with to 26.4% of patients taking placebo. In the second study, 33.3% and 33.9% of patients treated with Fycompa 8 mg and 12 mg, respectively, had a decrease in seizure frequency of at least 50%, compared with 14.7% of patients who they were taking placebo. The third study showed a significant decrease in seizure frequency only in patients taking Fycompa 4 mg and 8 mg, but not in patients taking a 2 mg dose.
What is the risk associated with Fycompa?
The most common side effects with Fycompa (seen in more than 1 in 10 patients) are dizziness and sleepiness. For the full list of side effects reported with Fycompa, see the leaflet
illustrative.
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, had a regular reduction in the frequency of seizures and that no serious toxicity was found. For this reason, the CHMP decided that Fycompa's benefits are greater than its risks and recommended that it be given a Marketing Authorization for the medicine.
Learn more about Fycompa
On 23 July 2012 the European Commission issued a "marketing authorization" for Fycompa, valid throughout the European Union.
For the complete version of Fycompa's EPAR, consult the Agency's website: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Fycompa therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 06-2012.
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