The US Food and Drug Administration (FDA) has approved perampanel oral suspension (Fycompa, Eisai Inc.) as adjunctive therapy for treatment of partial-onset seizures with or without secondarily generalized seizures, and primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older, the company has announced.
The oral suspension formulation is a bioequivalent, interchangeable alternative to the tablet formulation already approved.
Approval was based on a study that demonstrated bioequivalence between a single dose of perampanel oral suspension and a single dose of perampanel tablet, when administered under fasted conditions in healthy persons.
Perampanel is the first and only FDA-approved noncompetitive AMPA (α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) receptor antagonist. The precise mechanism by which it exerts its antiepileptic effects in humans is not fully understood.
Because it can be abused or lead to drug dependence, perampanel has been designated by the US Drug Enforcement Administration as a federally controlled substance (CIII).
The oral suspension formulation is expected to be available to patients in June of this year.
Perampanel may cause new or worse aggressive behavior, homicidal thoughts or threats, hostility, anger, anxiety, irritability, being suspicious or distrustful, and other unusual or extreme changes in behavior or mood, the statement notes. The combination of alcohol and perampanel may significantly worsen mood and increase anger.
Antiepileptic drugs, including perampanel, may cause suicidal thoughts or actions in about 1 in 500 people.
Along with dizziness, sleepiness, falls, tiredness, and problems walking normally, the most common side effects seen in patients receiving perampanel include headache, irritability, nausea, problems with muscle coordination, vertigo, and weight gain.
"We are excited about the approval of Fycompa Oral Suspension, as it gives another option to patients with epilepsy who may have difficulty swallowing tablets or prefer liquids," said Lynn Kramer, MD, chief clinical officer and chief medical officer, Neurology Business Group, Eisai, in the press release.
Brain & Nervous Resources
FDA Okays Oral Formulation of Perampanel (Fycompa). Medscape. May 02, 2016.