The Food and Drug Administration (FDA) has approved Nayzilam (midazolam) nasal spray for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 12 years of age and older.
The approval was based on data from the phase 3, placebo-controlled ARTEMIS 1 trial which evaluated the intranasal spray in 292 patients. The primary efficacy endpoint was treatment success, defined as the termination of seizures within 10 minutes after the initial blinded dose of study drug and the absence of a recurrence of seizures within 6 hours of the initial blinded dose of study drug.
Results showed that a statistically significantly higher percentage of Nayzilam-treated patients had treatment success compared with placebo (53.7% vs 34.3%; P =.011). In addition, a smaller proportion of patients treated with Nayzilam experienced seizure recurrence within 24 hours after the initial blinded dose of study drug (37.3% vs 46.3%); a statistically longer time-to-next-seizure was noted in Nayzilam-treated patients as well when compared with placebo.
With regard to safety, the most common adverse reactions in treated patients were somnolence, headache, nasal discomfort, throat irritation, and rhinorrhea. Nayzilam is a scheduled IV (CIV) controlled substance and carries a Boxed Warning regarding the risks associated with concomitant opioid use (ie, profound sedation, respiratory depression, coma, and death).
Nayzilam is supplied as a single-dose nasal spray unit that delivers midazolam 5mg in 0.1mL of solution. The treatment may be given by a caregiver following counseling on proper administration by a healthcare provider.
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