According to recent findings from the study published in the Journal of Epilepsia, researchers have observed that MDZ-NS 5 mg may provide an improvement over placebo for the treatment of intermittent bouts of increased seizure activity in the epilepsy monitoring unit.
Midazolam nasal spray (MDZ-NS) is indicated for 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 12 years of age and older with epilepsy. Hence, David C Spencer and associates from the Department of Neurology, Oregon Health & Science University, Portland, OR, USA carried out this trial basically aimed to evaluate the safety and efficacy of MDZ-NS in patients with epilepsy who were admitted to the epilepsy monitoring unit for seizure characterization/presurgical evaluation.
The authors carried out a randomized, double-blind, placebo-controlled phase 3 trial which included sixty eligible patients with ≥2 seizures in the 6-hour window preceding trial medication administration for whom treatment was appropriate based on the investigator's judgment was randomized (1:1) to MDZ-NS 5 mg or placebo. Efficacy outcomes were the proportion of patients seizure-free for 6 hours after treatment and time to first seizure within 6 hours. Safety and tolerability outcomes included treatment-emergent adverse events.
The following results were highlighted-
a. A higher proportion of patients on MDZ-NS than placebo were seizure-free for 6 hours following treatment (54.8% vs 38.7%); however, the 16.1% difference was not statistically significant (P = .1972).
b. The Kaplan-Meier curve of time to first seizure showed separation of both groups in favor of MDZ-NS from ~1.5 hours post-dose and throughout the 6-hour Treatment phase.
c. Median time to first seizure was not estimable for MDZ-NS (>50% of patients had no seizure) and 3.9 hours for placebo (P = .1388). TEAEs with MDZ-NS were generally comparable to those with placebo.
d. There were no deaths, serious TEAEs, or discontinuations due to TEAEs.
Therefore, the authors concluded that "although the observed treatment difference may be clinically meaningful, statistical significance was not demonstrated. Results suggest that MDZ-NS 5 mg may provide an improvement over placebo, with efficacy maintained for ≥6 hours post-dose. MDZ-NS was well tolerated in this population."