Analyses of patients who self-administered diazepam nasal spray for acute treatment of seizure clusters.

For acute treatment of seizure clusters in patients with epilepsy, intranasal administration of acute seizure therapies has been shown to provide accessibility and ease of use to care partners as well as the potential for self-administration by patients. Diazepam nasal spray (Valtoco®) was approved by the US Food and Drug Administration for acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) in patients with epilepsy aged ≥6 years. Self-administration consistent with the prescribing information is feasible and was reported by a subgroup of patients (n = 27 of 163) in a long-term phase 3 safety study. Data regarding self-administration among these patients with seizure clusters are examined here to explore the safety profiles and measures of effectiveness, as well as the quality of life of those who self-treated. In addition, this focused look at patients who self-administered diazepam nasal spray may offer some insights into the characteristics of patients who may be appropriate for self-administration.
Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr Misra was an employee of Neurelis, Inc., at the time of the development of this manuscript and has received stock options from Neurelis, Inc. Dr Sperling has received compensation for speaking at continuing medical education programs from Medscape, Projects for Knowledge, International Medical Press, and UCB Pharma. He has consulted for Medtronic; Neurelis, Inc.; and Johnson & Johnson. He has received research support from Eisai; Medtronic; Neurelis, Inc.; SK Life Science; Takeda; Xenon; Cerevel; UCB Pharma; Janssen; and Engage Pharmaceuticals. He receives royalties from Oxford University Press and Cambridge University Press. Dr Rao has served as a consultant for NeuroPace, Inc., manufacturer of the RNS® System. Dr Peters has served as a speaker and consultant for Neurelis, Inc.; SK Life Science; and Jazz Pharmaceuticals. Dr Penovich has served on speakers bureaus for Jazz Pharmaceuticals; Neurelis, Inc.; and UCB Pharma, and is an advisor to LVIS Corporation and Neurelis, Inc. Dr Wheless has served as an advisor or consultant for CombiMatrix; Eisai Inc.; GW Pharmaceuticals; Lundbeck, Inc.; Neurelis, Inc.; NeuroPace, Inc.; Supernus Pharmaceuticals, Inc.; and Upsher-Smith Laboratories, Inc. Dr. Wheless has served as a speaker or a member of a speakers bureau for: Cyberonics, Inc.; Eisai Inc.; Lundbeck, Inc.; Mallinckrodt; Neurelis, Inc.; Supernus Pharmaceuticals, Inc.; Upsher-Smith Laboratories, Inc., and has received grants for clinical research from Acorda Therapeutics; GW Pharmaceuticals; and INSYS. Dr Hogan has received research support from UCB Pharmaceuticals, Neurelis, Inc; and Biogen Inc, and is an advisor for Neurelis, Inc. Dr Davis is a consultant to Neurelis, Inc. Dr Carrazana is an employee of and received stock and stock options from Neurelis, Inc. Dr Rabinowicz is an employee of and has received stock options from Neurelis, Inc.
(© 2024 The Authors. Published by Elsevier Inc.)