Supplementary NDA is submitted in Japan for antiepileptic drug ,Fycompa injection formulation, as a new route of administration.

Fycompa is a first-in-class AED discovered at Eisai’s Tsukuba Research Laboratories. The agent is a highlyselective, noncompetitive AMPA receptor antagonist that is postulated to reduce neuronal hyper-excitation associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic membranes.

Two oral formulations of Fycompa are available in Japan: a tablet and a fine granule formulation. Due to concern about the risks associated with interruption of administration when the drug cannot be taken orally temporarily, such as during surgery, it is suggested that epilepsy patients should continue treatment other than via oral administration. The injection formulation was developed as a non-oral administration route to meet such medical needs, and its bioequivalence to the tablet formulation, as well as the confirmation of the safety and tolerability of the injection formulation when administered as an alternative therapy to the tablet, lead to this application.

The addition of an injection formulation of Fycompa, the only AMPA receptor antagonist-based AED, to the product lineup is expected to provide a new treatment option for a broader range of patients. It is estimated that there are approximately 1 million patients with epilepsy in Japan, and although onset occurs at any age, it is most common in people aged 18 and younger, and the elderly.