In December, midazolam nasal spray (Nayzilam; UCB, Atlanta, GA) will be available in retail pharmacies for acute treatment of intermittent, stereotypic seizure activity (eg, seizure clusters and acute repetitive seizures) in patients age 12 years or more with epilepsy.
Midazolam is a ready-to-use benzodiazepine solution used when a seizure cluster occurs that is distinct from a patient’s usual seizure pattern. The therapy can be administered by a nonhealthcare professional during or after a seizure.
Midazolam nasal spray was approved by the Food and Drug Administration (FDA) in May 2019. Approval was based on the randomized, placebo-controlled ARTEMIS 1 trial (NCT01390220). The trial showed treatment with 10 mg of midazolam delivered as 2 doses of nasal spray provided seizure termination within 10 minutes and without recurrence for 6 hours for 53.7% of trial participants vs 34.3% with placebo (P=0.011).
Numerical differences in favor of midazolam were observed on each component of treatment success: termination of seizure(s) within 10 minutes after initial dose of the therapy (80.6% versus 70.1%), and the absence of seizure recurrence between 10 minutes and 6 hours after the initial dose of the therapy (58.2% versus 37.3%).
For all seizure clusters treated with midazolam, the median time to return to full baseline functionality after drug administration was approximately 90 minutes.
"Seizure clusters are a medical emergency that can have very serious consequences for those living with them," said Laura Lubbers, PhD, chief scientific officer, Citizens United for Research in Epilepsy (CURE). "An effective seizure cluster rescue treatment, like Nayzilam, that is convenient and easily administered, along with a seizure cluster action plan, can change the lives of people living with seizure clusters and their families."
Allie Massaro, MD
Audrius V. Plioplys, MD
Jennifer Robblee, MD, MSc; Amaal J. Starling, MD; Rashmi B. Halker Singh, MD, FAHS, FAAN; and Nina Riggins, MD, PhD