DEA Delay Puts Epilepsy Drug Out of Reach for Patients

Eisai filed a petition with the U.S. Court of Appeals asking to direct the DEA to promptly schedule Fycompa (perampanel) so that it can be available to patients. Fycompa is an antiepileptic approved as an adjunctive therapy for the treatment of partial onset seizures with or without secondarily generalized seizures in patients >12 years old.

Fycompa was approved by the FDA in October 2012, and the Agency had sent its scheduling recommendation for Fycompa to the DEA in January 2013. However, the DEA has not yet begun the scheduling process.

Fycompa is a non-competitive AMPA glutamate receptor antagonist on post-synaptic neurons. Glutamate is the primary excitatory neurotransmitter in the central nervous system and is involved in a number of neurological disorders caused by neuronal over excitation. The exact mechanism of Fycompa’s antiepileptic effects has not been fully elucidated.

Fycompa will be supplied as 2mg, 4mg, 6mg, 8mg, 10mg, and 12mg film-coated tablets in 30- and 90-count bottles.

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