A critical evaluation of midazolam nasal spray for the treatment of patients with seizure clusters. (2nd November 2021)

• Record Type: Journal Article
• Authors: Wheless, James W
• Is Part Of: Expert review of neurotherapeutics. Volume 21:Number 11(2021)
• Page Start: 1195
• Page End: 1205
• Publication Date: 2021-11-02
• Subjects: Acute seizures -- epilepsy -- intranasal midazolam -- rescue therapy -- seizure clusters; Neuropharmacology -- Periodicals; 615.7805
• DOI: 10.1080/14737175.2021.1890033
• Languages: English
• ISSNs: 1473-7175

Abstract

ABSTRACT: Introduction : Patients with epilepsy may experience seizure clusters (SCs), which are considered a medical emergency requiring immediate treatment. Besides seizures and seizure-related injuries, patients with SCs experience impaired quality of life and have a greater need for healthcare resources. Midazolam nasal spray (MDZ-NS) was approved by the United States Food and Drug Administration (FDA) for the treatment of SCs in 2019, and was the first FDA-approved nasally administered formulation for treating SCs. Areas covered : This article provides a critical evaluation of MDZ-NS for the treatment of patients with SCs. It covers the chemistry, pharmacodynamic and pharmacokinetic properties of MDZ-NS, and safety, tolerability, and efficacy data from phase I and phase III trials. SC treatment guidelines in different countries and for alternative therapies are also discussed. Expert opinion : Midazolam is a well-established drug that is familiar to physicians. The newer MDZ-NS formulation offers the benefits of intranasal administration, which allows for outpatient treatment by caregivers and other non-healthcare professionals when an SC occurs, and may be particularly meaningful to patients with limited treatment options because other routes of administration are unsuitable. MDZ-NS is effective and patients are known to return to baseline alertness and psychomotor function within 240 minutes after administration.