New Formulation of Fycompa Approved for Seizure Disorders

Approval was based on a trial which displayed bioequivalence of the oral suspension & tablets
Approval was based on a trial which displayed bioequivalence of the oral suspension & tablets

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. 

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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.

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