Nayzilam™ (USL261; midazolam nasal spray, MDZ NS) is a novel nasal spray formulation of MDZ specifically developed as an acute rescue treatment for seizures in the outpatient setting for patients who require control of intermittent episodes of increased seizure activity (ie, acute repetitive seizures [ARS], seizure clusters [SC]).
This novel nasal spray formulation of MDZ provides convenient, non-invasive drug administration without active inhalation and can easily be given by caregivers when patients are experiencing an episode. The safety and efficacy of MDZ NS was evaluated in a randomized, double-blind, placebo-controlled, Phase 3 study (ARTEMIS-1; NCT01390220). This open label extension to ARTEMIS-1 was conducted to evaluate long-term safety and efficacy of repeated treatment of SC episodes (ARTEMIS-2, NCT01529034). Efficacy data are reported in a separate abstract (Sequeira et al, AES 2018).
The open-label ARTEMIS-2 study supports the long-term safety of repeated usage of MDZ NS in the outpatient setting to treat SCs. MDZ NS potentially offers caregivers a novel and reliable means of rescue treatment for patients experiencing SCs.