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Fycompa (PERAMPANEL)
Fycompa works by blocking the AMPA glutamate receptor, which is involved in the transmission of nerve impulses.
Fycompa (Perampanel) is a noncompetitive AMPA glutamate receptor antagonist developed by Eisai Inc. and currently owned by Catalyst Pharms. It is a small molecule modality that targets the glutamate receptor ionotropic AMPA, and was FDA approved in 2012 for the treatment of idiopathic generalized epilepsy, partial seizure, and secondarily generalized seizures. Fycompa has a long half-life of 183 hours and low bioavailability of 1%. It is available as a branded medication, with three generic manufacturers available.
At a glance
| Generic name | PERAMPANEL |
|---|---|
| Sponsor | Catalyst Pharms |
| Drug class | Noncompetitive AMPA Glutamate Receptor Antagonist [EPC] |
| Target | Glutamate receptor ionotropic AMPA |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2012 |
| Annual revenue | 300 |
Mechanism of action
Perampanel is non-competitive antagonist of the ionotropic -amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) glutamate receptor on post-synaptic neurons. Glutamate is the primary excitatory neurotransmitter in the central nervous system and is implicated in number of neurological disorders caused by neuronal over excitation.The precise mechanism by which FYCOMPA exerts its antiepileptic effects in humans is unknown.
Approved indications
- Idiopathic generalized epilepsy
- Partial seizure
- Secondarily generalized seizures
Boxed warnings
- WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS Serious or life-threatening psychiatric and behavioral adverse reactions including aggression, hostility, irritability, anger, and homicidal ideation and threats have been reported in patients taking perampanel ( 5.1). These reactions occurred in patients with and without prior psychiatric history, prior aggressive behavior, or concomitant use of medications associated with hostility and aggression ( 5.1). Advise patients and caregivers to contact a healthcare provider immediately if any of these reactions or changes in mood, behavior, or personality that are not typical for the patient are observed while taking perampanel or after discontinuing perampanel ( 5.1). Closely monitor patients particularly during the titration period and at higher doses ( 5.1). Perampanel should be reduced if these symptoms occur and should be discontinued immediately if symptoms are severe or are worsening ( 5.1). WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS See full prescribing information for complete boxed warning. Serious or life-threatening psychiatric and behavioral adverse reactions including aggression, hostility, irritability, anger, and homicidal ideation and threats have been reported in patients taking perampanel ( 5.1) Monitor patients for these reactions as well as for changes in mood, behavior, or personality that are not typical for the patient, particularly during the titration period and at higher doses ( 5.1) Perampanel should be reduced if these symptoms occur and should be discontinued immediately if symptoms are severe or are worsening ( 5.1)
Common side effects
- Dizziness
- Somnolence
- Fatigue
- Irritability
- Falls
- Nausea
- Ataxia
- Vertigo
- Weight gain
- Headache
- Vomiting
- Abdominal pain
Key clinical trials
- Senicapoc and Perampanel for Newly Diagnosed Glioblastoma (EARLY_PHASE1)
- Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression (PHASE1)
- Population Pharmacokinetics of Antiepileptic in Pediatrics
- Efficacy and Safety of Perampanel in the Treatment of Refractory Status Epilepticus (PHASE4)
- A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy (PHASE2)
- An Extended Access Program (EAP) for Perampanel
- Bioequivalence Assessment Between Two Perampanel Oral Suspension Formulations (PHASE1)
- Dual Anti-glutamate Therapy in Super-refractory Status Epilepticus After Cardiac Arrest
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Fycompa CI brief — competitive landscape report
- Fycompa updates RSS · CI watch RSS
- Catalyst Pharms portfolio CI