Abstract Details

Title Safety of a Second Dose of Diazepam Nasal Spray Within 4 Hours in Patients With Seizure Clusters: Final Results From a Long-Term, Phase 3, Open-Label, Repeat-Dose Safety Study

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P14 - Poster Session 14 (11:45 AM-12:45 PM)

Poster/Presentation
Number 10-003

Objective

This exploratory analysis evaluated the safety of second doses of diazepam nasal spray (Valtoco^®) within 4 hours of the first dose in a long-term, phase 3, open-label, repeat-dose safety study.

Background Second doses of diazepam rescue therapy for seizure clusters, if needed, are typically given 4-12 hours after the initial dose, based on the rectal-gel clinical development program. Untreated, approximately one-third of second seizures in clusters take place within 4 hours of the first; thus, waiting to administer a second dose may be a limitation.

Design/Methods Patients were aged 6-65 years who experienced seizure clusters. Patients and care partners administered age- and weight-based doses of diazepam nasal spray; if needed, a second dose could be administered 4-12 hours later. Investigators could adjust dosing. This analysis assessed the safety of diazepam nasal spray in patients treated with ≥1 second dose within 4 hours and 4-24 hours after the first dose.

Results Of 175 enrolled patients, 163 received ≥1 dose of diazepam nasal spray (mean age, 23.1 years; 54.6% female); 3853 seizure clusters were treated with 4390 total doses. Of these, 485 were second doses given to 79 (48.5%) patients; 38 (23.3%) patients received ≥1 second dose within 4 hours (152 doses), and 41 (25.2%) received second doses within 4-24 hours (333 doses). Rates of treatment-emergent adverse events (TEAEs) were similar between the groups. The most common treatment-related TEAEs in the <4-hours group were of mild or moderate severity. No treatment-related discontinuations or serious TEAEs were reported in either group.

Conclusions There were few treatment-related TEAEs in patients receiving a second dose of diazepam nasal spray within 4 hours of the first, which was similar to patients receiving second doses at 4-24 hours. The results for both subgroups were consistent with an interim analysis and the established profile for rectal diazepam.

Authors/Disclosures
Gregory D. Cascino, MD, FAAN (Mayo Clinic) PRESENTER	Dr. Cascino has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for International League Against Epilepsy . Dr. Cascino has received intellectual property interests from a discovery or technology relating to health care. Dr. Cascino has received publishing royalties from a publication relating to health care. Dr. Cascino has received publishing royalties from a publication relating to health care.
Jay D. Desai, MD	Dr. Desai has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aquestive. The institution of Dr. Desai has received research support from Neurelis, Aquestive, Ovid, Novartis, UCB.
Daniel C. Tarquinio, DO	The institution of Dr. Tarquinio has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurelis.
James W. Wheless, MD, FAAP, FACP, FAAN, FAES, FCNS, FAAN (UTHSC-Pediatric Neurology)	Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jazz. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurelis. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Azurity. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biocodex. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for LivaNova. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Stoke. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for LivaNova. Dr. Wheless has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Jazz. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for UCB. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for UCB. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Neurelius.
Robert E. Hogan, MD (Washington Univ in St Louis/Neuro Dept)	Dr. Hogan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurelis. The institution of Dr. Hogan has received research support from Biogen Inc. The institution of Dr. Hogan has received research support from Engage Therapeutics. The institution of Dr. Hogan has received research support from Otsuka Pharmaceuticals. The institution of Dr. Hogan has received research support from Cerevel Therapeutics.
Michael R. Sperling, MD, FAAN (Thomas Jefferson University)	Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurelis. The institution of Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for UCB Pharma. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Medscape. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for International Medical Press. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Projects for Knowledge. The institution of Dr. Sperling has received research support from SK Life Science. The institution of Dr. Sperling has received research support from UCB Pharma . The institution of Dr. Sperling has received research support from Takeda. The institution of Dr. Sperling has received research support from Neurelis. The institution of Dr. Sperling has received research support from Engage Therapeutics . The institution of Dr. Sperling has received research support from Medtronic. The institution of Dr. Sperling has received research support from Cavion. The institution of Dr. Sperling has received research support from Xenon Pharma. The institution of Dr. Sperling has received research support from Cerevel. The institution of Dr. Sperling has received research support from National Institutes of Health . The institution of Dr. Sperling has received research support from DARPA. Dr. Sperling has received publishing royalties from a publication relating to health care. Dr. Sperling has received publishing royalties from a publication relating to health care. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Vice President with Epilepsy Consortium .
Kore K. Liow, MD, FACP (University of Hawaii, John Burns School of Medicine)	The institution of Dr. Liow has received research support from UCB. The institution of Dr. Liow has received research support from Livanova. The institution of Dr. Liow has received research support from Biogen. The institution of Dr. Liow has received research support from Novartis. The institution of Dr. Liow has received research support from Eisai. The institution of Dr. Liow has received research support from Engage Therapeutics. The institution of Dr. Liow has received research support from SK Lifescience. The institution of Dr. Liow has received research support from Cerevel. The institution of Dr. Liow has received research support from Xenon. The institution of Dr. Liow has received research support from NeuroDerm. The institution of Dr. Liow has received research support from Avanir. The institution of Dr. Liow has received research support from Annovis. The institution of Dr. Liow has received research support from Acadia. The institution of Dr. Liow has received research support from Prothena. The institution of Dr. Liow has received research support from SAGE. The institution of Dr. Liow has received research support from Annovis. The institution of Dr. Liow has received research support from Cyclerion.
Sunita N. Misra, MD (SK Life Science)	Dr. Misra has received personal compensation for serving as an employee of SK Life Science, Inc. An immediate family member of Dr. Misra has received personal compensation for serving as an employee of Neurocrine Biosciences.
	No disclosure on file
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.

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