Nayzilam (midazolam nasal spray; UCB) will soon be available 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 product was approved in May based on data from the phase 3, placebo-controlled ARTEMIS 1 trial that evaluated the safety and efficacy of the intranasal benzodiazepine in 292 patients. Results showed that a statistically significantly higher percentage of Nayzilam-treated patients had treatment success, defined as the termination of seizures within 10 minutes and the absence of a recurrence of seizures within 6 hours, compared with placebo (53.7% vs 34.3%; P =.011). As for safety, the most common treatment-emergent adverse reactions were somnolence, headache, nasal discomfort, throat irritation and rhinorrhea.

Nayzilam, a Schedule IV controlled substance, carries a Boxed Warning regarding the risks associated with concomitant opioid use (ie, profound sedation, respiratory depression, coma, and death). In patients at increased risk of respiratory depression from benzodiazepines, administration of Nayzilam under healthcare professional supervision should be considered; this can be performed in the absence of a seizure episode. 

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Nayzilam is supplied as a single-dose nasal spray unit containing 5mg of midazolam in 0.1mL solution. The product will be available in retail pharmacies on December 2, 2019; copay support and a patient assistance program will be available through UCB.

“For the first time, people 12 years and older now have a nasally-administered rescue therapy shown to help manage seizure clusters,” said Mike Davis, Head of Neurology in the US, UCB. “Nayzilam can be administered anywhere seizure clusters strike, allowing families to take back valuable moments that would otherwise be lost.”

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