New Formulation Expands Treatment Options for Epilepsy Patients with POS and PGTC Seizures
Woodcliff Lake, NJ, May 2, 2016 – Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved FYCOMPA® (perampanel) CIII Oral Suspension as adjunctive therapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures, and primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older. The oral suspension formulation is a bioequivalent, interchangeable alternative to the FYCOMPA tablet formulation, and is expected to be available to patients in June 2016.
“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, M.D., Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. “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.”
The approval of FYCOMPA Oral Suspension was based on a bioequivalence (BE) study that demonstrated BE between a single dose of perampanel oral suspension and a single dose of perampanel tablet, when administered under fasted conditions in healthy subjects.
About FYCOMPA
FYCOMPA (perampanel) is indicated as adjunctive therapy for the 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.