FDA to Review Fycompa for Monotherapy Use in Partial-Onset Seizures

The label change would include use as a monotherapy for partial-onset seizures
The label change would include use as a monotherapy for partial-onset seizures

Eisai announced the submission of a supplemental application for a proposed label change for Fycompa (perampanel) which would include use as monotherapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in patients with epilepsy ≥12 years. 

Fycompa, a CIII controlled substance, is already indicated as an adjunctive therapy in combination with another antiepileptic drug for the treatment of POS with or without secondarily generalized seizures, and primary generalized tonic-clonic seizures in patients with epilepsy ≥12 years. 

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Fycompa is an oral non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) receptor antagonist. The precise mechanism by which Fycompa exerts its antiepileptic effects has not been fully elucidated. It is available as 2mg, 4mg, 6mg, 8mg, 10mg, and 12mg strength tablets as well as a recently launched 0.5mg/mL strength oral suspension in 340mL bottles.

For more information call (888) 274-2378 or visit Fycompa.com.