New Formulation of Fycompa Approved for Seizure Disorders
Eisai announced that the Food and Drug Administration (FDA) has approved Fycompa (perampanel) 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 aged ≥12 years.
Fycompa Oral Suspension, a CIII controlled substance, is bioequivalent and interchangeable with Fycompa tablets. The FDA approval was based on a study that showed bioequivalence between a single dose of the oral suspension and a single dose of the tablets when given to healthy subjects under fasted conditions.
Perampanel is a non-competitive antagonist of the ionotropic AMPA glutamate receptor on post-synaptic neurons. Glutamate is the primary excitatory neurotransmitter in the central nervous system and is implicated in a number of neurological disorders caused by neuronal over-excitation.
Fycompa Oral Suspension will be available as a 0.5mg/mL strength in 340mL bottles. It is expected to be available in June 2016. Fycompa tablets are already available as 2mg, 4mg, 6mg, 8mg, 10mg, and 12mg strengths in 30- and 90-count bottles.
For more information call (888) 274-2378 or visit Fycompa.com.