FDA Approves Nayzilam (Midazolam) for Seizure Activity in Patients with Epilepsy

May 20, 2019

Nayzilam is a benzodiazepine antiepileptic nasal spray.

Nayzilam (midazolam) nasal spray is an antiepileptic drug (AED) benzodiazepine indicated for acute treatment of intermittent stereotypic episodes of frequent seizure activity distinct from an epileptic patient’s usual seizure pattern. The types of epilepsy activity included in the drug’s prescribing information include seizure clusters and acute repetitive seizures. 

Midazolam was originally approved in the United States in 1985; however, this recent new drug application serves as the drug’s first approval in more than 20 years and currently stands as the first and only FDA-approved nasal option for treating seizure clusters. 

Designed as a single-use treatment, Nayzilam can be carried with a patient and administered by a nonhealthcare professional if the patient experiences an epileptic seizure. 

The drug’s effectiveness was established in a randomized double-blind placebo-controlled trial. Out of the 201 patients included in the study, 134 patients received a blinded 5-mgdose of Nayzilam and 67 patients received the placebo. 

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Within 10 minutes after initial dose, 80.6% of the Nayzilam group experienced termination of seizures, compared to 70.1% of the placebo group. Between 10 minutes and six hours after initial dose, 58.2% of the Nayzilam group did not experience a recurrence of a seizure episode, compared with 37.3% of the placebo group. 

The most common adverse events reported in the study included somnolence, headache, nasal discomfort, throat irritation, and rhinorrhea. 

Nayzilam is contraindicated for patients with hypersensitivity to midazolam and/or have acute narrow-angle glaucoma. 

According to the CDC, about 3.4 million people in the U.S. experienced active epilepsy in 2015, including roughly three million adults and 470,000 children. 0.6% of children from infancy to 17 years of age are estimated to have active epilepsy.