FDA Approves Anti-Epileptic Nasal Spray

The US Food and Drug Administration (FDA) has approved a new drug application for the anti-epileptic drug midazolam (Nayzilam®) nasal spray CIV for the acute treatment of intermittent stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in patients with epilepsy 12 or older.

The benzodiazepine, developed by UCB Inc., is the first FDA-approved nasal option for treating seizure clusters and is the first new medication in the US approved to treat seizure clusters in more than 20 years.

"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. "Further, as a neurologist specializing in epilepsy, treating seizure clusters today presents a challenging barrier for many patients. The availability of a new treatment option, such as (midazolam), has potential to help improve the lives of patients and their families by providing another option for rescue care."

Midazolam is a short-term treatment designed for single-use that can be carried with a. patients. It allows for administration by a non-healthcare professional in patients actively seizing.

Approval is based on the results of a randomized, double-blind, placebo-controlled study. Numerous differences were observed in the study when comparing midazolam to placebo therapy, termination of seizures within 10 minutes of initial dose was higher in the midazolam group (80.6% versus 70.1%) and the absence of seizure recurrence between 10 minutes after 6 hours after initial dosing (58.2% versus 37.3%).

Results also showed that midazolam-treated patients experienced a statically longer time-to-next-seizure than the placebo group. A smaller proportion of midazolam-treated patients experienced the next seizure within 24 hours after the initial blinded dose of midazolam (37.3% versus 46.3%).

UCB Inc anticipates midazolam nasal spray to be available within the US later this year.