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# FDA Accepts UCB NDA for Seizure Nasal Spray
- URL: https://www.fdaweb.com/fda-accepts-ucb-nda-for-seizure-nasal-spray/
- Published: 2018-08-13T12:00:00.000Z
- Updated: 2026-09-15T00:25:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142096

FDA has accepted for review a UCB NDA for midazolam nasal spray, an investigational product 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 submission is based on data from the Phase 3 clinical study (ARTEMIS 1 -Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray), which evaluated the safety and efficacy of midazolam nasal spray in 292 patients. The spray has been granted both orphan drug and fast track designations by the agency.