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news.The US Food and Drug Administration (FDA) has approved Eisai’s Fycompa (perampanel) oral suspension as adjunctive therapy to treat partial-onset seizures (POS) with or without secondarily generalized seizures, and primary generalized tonic-clonic (PGTC) seizures.
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Fycompa is already available in 43 countries in 2 mg, 4 mg, 6 mg, and 8 mg, 10 mg, and 12 mg tablets.
The updated formulation is now a CIII oral suspension, which is intended for patients with epilepsy aged 12 years or more.
The oral suspension formulation is a bioequivalent, interchangeable alternative to the Fycompa tablet formulation, approved by the FDA in October 2012. It is anticipated to be available next month.
The approval was based on a study that showed bioequivalence between a single dose of perampanel oral suspension and a single dose of perampanel tablet, when given to healthy patients under fasted conditions.
Eisai chief clinical officer and chief medical officer of neurology business group Lynn Kramer said: "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.
"The development of this new formulation underscores Eisai’s commitment to advancing epilepsy care by making contributions to help address the diversified needs of epilepsy patients and their families."
Fycompa is the first and only FDA-approved noncompetitive AMPA (a-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.
Epilepsy produces seizures affecting several mental and physical functions. According to the Institute of Medicine, epilepsy is one of the most common neurological disorders, affecting 2.9 million people in the US.
Image: Fycompa is already available in 43 countries in 2 mg, 4 mg, 6 mg, and 8 mg, 10 mg, and 12 mg tablets. Photo: courtesy of zole4/FreeDigitalPhotos.net.