FDA Clears Nayzilam as First Nasal Spray to Treat Seizure Clusters

The FDA approved UCB's Nayzilam (midazolam) nasal spray, a single-dose benzodiazepine used for acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients 12 years of age and older.

Nayzilam can be given by a non-healthcare provider such as a caregiver or family member.

In a Phase 3 study, 201 patients were on stable seizure treatment but experiencing seizure clusters. A significantly greater percent of patients met the primary endpoint, defined as termination of seizure(s) within 10 minutes after the initial dose of Nayzilam 5 mg or placebo (80.6 versus 70.1%) and the absence of seizure recurrence between 10 minutes and 6 hours after the initial dose (58.2 versus 37.3%).

The most common side effects were drowsiness (somnolence), headache, nasal discomfort, throat irritation, and runny nose (rhinorrhea).

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