FDA Approves Midazolam Nasal Spray for Treating Frequent Seizures

The nasally administered benzodiazepine spray midazolam (Nayzilam; UCB, Smyrna, GA) has been approved by the Food and Drug Administration (FDA) for acute treatment of frequent seizure activity in people age 12 and up with epilepsy. The nasal spray is a single-use treatment that can be administered when a seizure cluster occurs. Midazolam is the first new medication approved for treating seizure clusters in more than 20 years in the US.

In a randomized double-blind clinical trial (NCT01390220), a statistically significant higher proportion of seizure episodes treated with midazolam (n = 134) terminated within 10 minutes of treatment compared with placebo (n = 67). Numerical differences in favor of the drug were observed on each component of treatment success: termination of seizure(s) within 10 minutes after initial dose versus placebo (80.6% versus 70.1%) and absence of seizure recurrence between 10 minutes and 6 hours after the initial dose (58.2% versus 37.3%). 

The study also evaluated the time to next seizure after the initial dose. A smaller proportion of patients treated with midazolam experienced the next seizure within 24 hours after the initial dose versus placebo (37.3% versus 46.3%).  

"When a patient experiences seizure clusters, there is often significant impact on their overall quality of life, in addition to posing greater risks for increased emergency department-related hospitalizations and more serious seizure emergencies," said Dr. Steven S. Chung, MD, executive director and program chair of the Neuroscience Institute and director of the Epilepsy Program at Banner--University Medical Center. "The availability of a new treatment option, such as Nayzilam, has potential to help improve the lives of patients and their families by providing another option for rescue care."

Participants in the trial were taking antiepileptic drugs but still had intermittent stereotypic episodes of frequent seizure activity distinct from their usual seizure pattern.