Abstract Details

Title Timing to Administration and Ease of Dosing of Diazepam Nasal Spray Rescue Therapy for Seizure Clusters: Results From a Phase 3, Long-Term Open-Label, Repeat-Dose Safety Study

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P15 - Poster Session 15 (5:30 PM-6:30 PM)

Poster/Presentation
Number 10-001

Background Seizure clusters require prompt treatment to lower risk of associated morbidities. Diazepam nasal spray provides a quick, noninvasive, socially acceptable route of administration for acute treatment for seizure clusters in an easy-to-use portable device.

Objective This analysis of a long-term safety study examined time to administration and ease of use of diazepam nasal spray (Valtoco^®) for patients with epilepsy experiencing seizure clusters.

Design/Methods

The study included patients aged 6-65 years with epilepsy and seizure clusters. Patients and caregivers were trained to administer diazepam nasal spray in age- and weight-based doses. Patient diaries recorded seizure timing and drug administration. Surveys were distributed to patients and caregivers at study end, completion, or discontinuation to collect ease-of-use data for diazepam nasal spray.

Results Of 175 patients enrolled, 163 received ≥1 dose of study treatment (54.6% female, mean age, 23.1 years). Time to administration was available for 3627 seizures (162 patients). Patients received treatment within 2 minutes of the start of 50% of seizures, and 75% were treated within 5 minutes. Eighty-four caregivers and 67 patients responded to the survey. Of 27 patients reporting self-administration on the survey, 50% of seizures that occurred were treated within 2 minutes and 75% within 10 minutes. In the survey, diazepam nasal spray administration was rated extremely or very easy by 93.8% of 84 caregivers and by 77.8% of self-administering patients. Overall, treatment-related adverse events occurred in 18.4% of patients (29.6% of self-administering patients).

Conclusions Patients and caregivers reported rapid diazepam administration (75% of seizures treated within 5 minutes). In the survey, ≥75% considered administration extremely or very easy; 40% of surveyed patients reported self-administration. This is meaningful for clinicians, as rapid time to seizure cluster control is critical to reduce morbidity and the risk of progression to status epilepticus and mortality.

Authors/Disclosures
Sunita N. Misra, MD (SK Life Science) PRESENTER	Dr. Misra has received personal compensation for serving as an employee of Neurelis, Inc. An immediate family member of Dr. Misra has received personal compensation for serving as an employee of Neurocrine Biosciences. Dr. Misra has received personal compensation in the range of $500-$4,999 for serving as a Consultant for RubiconMD. Dr. Misra has received intellectual property interests from a discovery or technology 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.
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.
James W. Wheless, MD, FAAP, FAAN (UTHSC-Pediatric Neurology)	Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Supernus. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aquestive. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Greenwich. 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 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 Eisai. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Supernus. Dr. Wheless has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Greenwich. 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 BioMarin. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Zogenix. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Neurelius.
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.
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.
Dennis J. Dlugos, MD	Dr. Dlugos has received research support from NIH. The institution of Dr. Dlugos has received research support from The Epilepsy Study Consortium.
Gregory D. Cascino, MD, FAAN (Mayo Clinic)	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.
	No disclosure on file
Enrique Carrazana	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.