The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for a novel, investigational midazolam formulation for the acute treatment of seizures in patients who require control of intermittent bouts of increased seizure activity (e.g. seizure clusters, acute repetitive seizures). The product is intended to be delivered intranasally without active inhalation by the patient.
The NDA includes data from the Phase 3 ARTEMIS 1 trial which evaluated the intranasal spray in 292 patients. Results showed the treatment appeared to be safe and effective in patients with seizure clusters, providing evidence that it could be a viable alternative to rectal diazepam. Treatment emergent adverse events were found to be related to the route of administration and the pharmacology of midazolam.
The treatment was previously granted Orphan Drug and Fast Track designation by the Agency. The Company indicated in a press release that they hope acceptance of the NDA will lead to approval sometime in 2019.
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