Posted by Eisai Co., Ltd. announced that they have obtained marketing authorization approval from the Japanese authorities for an injection formulation of their in-house discovered antiepileptic drug Fycompa® (perampanel) in Japan as an alternative therapy when oral administration is not possible [1].
Fycompa is a first-in-class drug discovered at Eisai’s Tsukuba Research Laboratories. The agent is a highly selective, 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 of seizures 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 via routes other than oral administration.
Since Fycompa is the only AMPA receptor antagonist-based antiepileptic drug, Eisai developed this injection formulation to meet the needs of patients who are unable to use oral administration, and filed a supplementary new drug application as a new route of administration in August 2022, leading to this approval.
One dosage unit of Fycompa® for intravenous infusion, contains 2.16 mg perampanel hydrate (eq. 2.08 mg of perampanel), 1040 mg SBECD, as well as phosphoric acid and sodium hydroxide for pH setting.