Midazolam nasal spray (Nayzilam; UCB, Atlanta, GA) was approved by the Food and Drug Administration (FDA) in May 2019 for acute treatment of intermittent stereotypic seizure activity (eg, seizure clusters and acute repetitive seizures) in individuals age 12 years or more. The nasal spray became available in pharmacies in December 2019. Midazolam can be self-administered or administered by a caregiver outside of the healthcare setting.
In the ARTEMIS clinical trial (NCT01390220), midazolam nasal spray was proven to more effective than placebo at stopping seizures within 10 minutes with no seizure recurrence within 6 hours (53.7% vs 34.3%; P=.011). Of note, half of the participants (median) had a return to their baseline function within 90 minutes of treatment, which was similar to what was seen with placebo. For participants who stopped a seizure cluster with nasal midazolam, there was a 20% likelihood of no seizure recurrence within 24 hours. Data suggest that recovery of function is driven more by duration of the postictal state than the effects of the drug.
Rita Campos, PharmD, associate medical director of neurology at UCB Pharma said, “Our hope is that the ability to be treated in the community will create a greater sense of control and independence for people living with repetitive seizure clusters. Nayzilam has the potential to become a part of the disease journey that frees people from some of the limitations to daily living caused by cluster seizures, which they have shared with us as a previously unmet need.”
Mike Davis, head of neurology at UCB said, “We are focused not only on new treatments, but on making sure that we are helping the right person get the right treatment at the right time. We hope that having a new treatment for cluster seizures that can be self- or caregiver-administered allows people to return to function quickly, improve quality of life, and lessen the isolation that is prevalent among most people who experience cluster seizures.”
In a post hoc analysis of safety data presented at the American Epilepsy Society Annual Meeting in Baltimore, MD December 6-10, 2019, incidences of treatment-emergent adverse events included somnolence, headache, nasal irritation, and lacrimation. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.