FDA To Consider Midazolam Nasal Spray for Acute Cluster Seizure Treatment

The US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for an investigational nasal spray therapy intended for the acute treatment of seizure clusters.

Midazolam Nasal Spray—from global biopharmaceutical company UCB, Brussels, Belgium (UCB)—has been previously granted Orphan Drug and Fast Track designations by the FDA. It’s now set for a potential market approval in early 2019.

The spray’s application is supported by data from the phase 3 Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray (ARTEMIS 1) trial, in which a 5mg intranasal dose of the therapy was tested for efficacy and safety in 292 patients with seizure clusters in a randomized, double-blind, placebo-controlled setting.

Investigators had tested for a primary endpoint of seizure termination within 10 minutes following therapy administration, as well as no recurring seizures from 10 minutes to 6 hours following administration. The study had concluded in March.

UCB has previously acquired the midazolam nasal spray from research foundation Proximagen in June, with both companies collaborating on the NDA filing. If approved, midazolam would be the first new therapy approved for seizure clusters in 17 years.

Seizure clusters—estimated to affect 150,000-plus US patients with refractory epilepsy—are commonly unpredictable events, even in patients adhering to anti-epileptic therapy regimens. The condition often drives annual rates of emergency room visits and hospitalizations, and require an acute care plan with immediate patient access.

Jeff Wren, head of Neurology and executive vice president at UCB, said that managing seizure clusters remains a challenge for “thousands of patients and caregivers.”

“There is an unmet need for effective and convenient acute treatment of seizure clusters that can rapidly end ongoing seizures and potentially prevent or delay their reoccurrence,” Wren said in a statement. “With midazolam nasal spray, UCB hopes to expand and diversify the treatment choices we provide to the epilepsy community, complementing our already strong epilepsy portfolio and providing additional solutions to help patients.”