2 May 2016 - Eisai Inc. today announced that the U.S. FDA has approved Fycompa (perampanel) oral suspension 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.
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.
The approval of Fycompa oral suspension was based on a bioequivalence 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.
For more details, go to: http://eisai.mediaroom.com/2016-05-02-Eisai-Announces-FDA-Approval-of-FYCOMPA-perampanel-Oral-Suspension-for-Adjunctive-Therapy-in-the-Treatment-of-Partial-Onset-Seizures-and-Primary-Generalized-Tonic-Clonic-Seizures