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Abstract Details

Treatment of Prolonged Seizure With Diazepam Nasal Spray: A Post Hoc Cohort Analysis
Epilepsy/Clinical Neurophysiology (EEG)
P12 - Poster Session 12 (11:45 AM-12:45 PM)
9-001
To assess the use of diazepam nasal spray (Valtoco®) in prolonged seizures in a seizure cluster (SC). 

Benzodiazepines are first-line rescue therapy in seizure emergencies, including SCs and prolonged seizures, and can be used promptly when indicated. Diazepam nasal spray is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, SCs) in patients with epilepsy aged ≥6 y. Diazepam nasal spray treatment of SCs within 5 minutes has been associated with seizure termination in ≤2 minutes.

This post hoc sensitivity analysis of data from a long-term safety study of diazepam nasal spray analyzed prolonged seizures within SCs (treated 5–15 min after seizure start) by age (<18 y, ≥18 y), epilepsy type (generalized, focal, unclassified), and SC burden (≥20 SCs). Second dose usage was a proxy for effectiveness.
In SCs treated 5–15 minutes after seizure start (n=727 events), an earlier analysis found that the median time from drug administration to seizure termination was 7 minutes. Sensitivity analyses reported generally similar results, with median times to seizure termination of 5 and 10 minutes for pediatric and adult patients; 6, 5, and 15 minutes for generalized, focal, and unclassified epilepsies; and 10 minutes in patients with ≥20 SCs. Second doses were administered in 9.3% of prolonged events; generally consistent across subgroups. 82.2% of patients had ≥1 treatment-emergent adverse event (TEAE) during 1.5 years on average. 30.7% patients had a serious TEAE, and 18.4% had TEAEs deemed related to study drug (none were serious). No cardiorespiratory depression was reported.
If treatment is delayed (ie, a prolonged seizure within a SC), diazepam nasal spray rapidly terminates the SC with high first-dose effectiveness and a well-characterized safety profile. Diazepam nasal spray controls SCs when used promptly and when seizures are prolonged. 
Authors/Disclosures
Steven T. Whitworth, PhD (Neurelis)
PRESENTER 		Dr. Whitworth has received personal compensation for serving as an employee of Neurelis Inc..
Randa G. Jarrar, MD Dr. Jarrar has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neuralis.
John M. Stern, MD, FAAN Dr. Stern has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for UCB Pharma. Dr. Stern has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for SK Life Science. Dr. Stern has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurelis. Dr. Stern has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Ceribell. Dr. Stern has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Jazz Pharma. Dr. Stern has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for LivaNova. Dr. Stern has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Neurelis. Dr. Stern has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for LivaNova. Dr. Stern has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sunovion. Dr. Stern has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Jazz. Dr. Stern has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for SK Life Sciences. Dr. Stern has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for MedLink Neurology. Dr. Stern has stock in DEARhealth. Dr. Stern has stock in Ceribell. Dr. Stern has received publishing royalties from a publication relating to health care. Dr. Stern has received publishing royalties from a publication relating to health care. Dr. Stern has received publishing royalties from a publication relating to health care. Dr. Stern has received publishing royalties from a publication relating to health care.
Danielle A. Becker, MD Dr. Becker has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neurelis, Inc. Dr. Becker has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sk life Science. Dr. Becker has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Supernus Pharmaceuticals. Dr. Becker has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Neurelis, Inc. Dr. Becker has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sk Life Science. Dr. Becker has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Jazz pharmaceuticals. Dr. Becker has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for UBC. Dr. Becker has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for LivaNova. Dr. Becker has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Neuropace. Dr. Becker has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Supernus Pharmaceuticals.
Adrian L. Rabinowicz, MD, FAAN (Neurelis, Inc.; Center for Molecular Biology and Biotechnology, Charles E. Schmidt College of Science, Florida Atlantic University) Dr. Rabinowicz has received personal compensation for serving as an employee of Neurelis, Inc. Dr. Rabinowicz has stock in Neurelis, Inc.
Enrique Carrazana (Neurelis, Inc.) Enrique Carrazana has received personal compensation for serving as an employee of Neurelis. Enrique Carrazana has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Hawaii-Biotech, CND Life Sciences, Apex Labs. Enrique Carrazana has stock in Neurelis, CND, Apex.