Posted by Michael Wonder on 13 Aug 2018
FDA accepts new drug application to review midazolam nasal spray, an investigational product for the acute treatment of seizure clusters
13 August 2018 - Midazolam nasal spray has also been granted fast track designation by the US FDA due to the high unmet need for patients and caregivers.
UCB today announced that the U.S. FDA has accepted the filing of a new drug application 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 application is supported by data from a 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.
