Resubmitted NDA Accepted for Perampanel for Seizures

Eisai Inc. announced that the FDA has accepted the resubmitted New Drug Application (NDA) for perampanel for the treatment of partial-onset seizures associated with epilepsy. This resubmission comes after the FDA issued a Refusal to File letter in July 2011 in which FDA requested reformatting and reanalyses of some datasets in the dossier. The application was originally submitted in May 2011.

Perampanel is an orally administered, highly selective non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid)-type glutamate receptor antagonist. The AMPA receptor is widely present in almost all excitatory neurons.

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