Treatment of Status Epilepticus At and After T1 With Diazepam Nasal Spray: A Combined Cohort Analysis
Eric Segal1, John Stern2, Danielle Becker3, Randa Jarrar4, Tracy Glauser5, Jurriaan Peters6, Evelyn Shih7, Enrique Carrazana8, Adrian Rabinowicz9
1Hackensack University Medical Center, Northeast Regional Epilepsy Group, and Hackensack Meridian School of Medicine, 2Geffen School of Medicine, University of California Los Angeles, 3Ohio State University Wexner Medical Center, 4Phoenix Children’s Hospital, 5Comprehensive Epilepsy Center, Cincinnati Children’s Hospital, 6Boston Children’s Hospital and Harvard Medical School, 7Neurelis, Inc., 8Neurelis, Inc.; University of Hawaii, John A. Burns School of Medicine, 9Neurelis, Inc; Center for Molecular Biology and Biotechnology, Charles E. Schmidt College of Science, Florida Atlantic University
Objective:
To assess diazepam nasal spray (Valtoco®) to treat early status epilepticus (SE) episodes in patients with epilepsy.
Background:
SE is defined as abnormally prolonged seizures continuing after time point T1 (per ILAE: 5 minutes for generalized; 10 for focal seizures). Treatment of seizure clusters with diazepam nasal spray ≥5 minutes after onset was shown to be effective for seizure termination. Diazepam nasal spray is approved for seizure-cluster treatment in patients with epilepsy aged ≥6y.
Design/Methods:
Data (April 20, 2024 cutoff) from an ongoing study of patients aged 2–5y and from the long-term safety study of patients 6–11y, 12–17y and, in a separate analysis, 18–65y were evaluated by age group and seizure type for time from treatment to seizure episode termination. Unclassified seizures were excluded.
Results:
Proportions of generalized seizure episodes treated after T1 by age group were: 2–5y, 38.5% (35/91); 6–11y, 17.7% (107/606); 12–17y, 15.9% (102/641); ≥18y, 20.9% (63/301). Median times to termination were 1, 5, 6, and 15 minutes. Proportions of focal seizure episodes were: 2–5y, 12.0% (11/92); 6–11y, 7.1% (3/42); 12–17y, 9.6% (11/115); ≥18y, 26.5% (228/859). Median times to termination were 2, 110, 14, and 20 minutes. Eight SE episodes were reported as not treatment-related serious treatment-emergent adverse events (TEAEs) requiring hospitalization/prolongation by 5 patients 2–5y (n=36; 13.9%); 7 episodes in 5 patients 6–11y (n=45; 11.1%); 2 episodes in 1 patient 12–17y (n=33; 3.0%), and 1 episode in 1 patient ≥18y (n=85; 1.2%). Diazepam nasal spray’s safety profile was supported.
Conclusions:
In patients 2–65y with seizure episodes reaching T1, diazepam nasal spray provided consistent control, and the majority of these episodes were not associated with hospitalization as serious TEAEs. Diazepam nasal spray demonstrated safety and tolerability in patients 2–65y.
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