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REVIEW

Taking a Newer, Faster, Intranasal Route: A Narrative Review of Transitioning to a Less-Invasive Rescue Treatment for Seizure Clusters

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Pages 383-389 | Received 01 Nov 2023, Accepted 23 Jan 2024, Published online: 06 Feb 2024

References

  • Cloyd J, Haut S, Carrazana E, Rabinowicz AL. Overcoming the challenges of developing an intranasal diazepam rescue therapy for the treatment of seizure clusters. Epilepsia. 2021;62(4):846–856. doi:10.1111/epi.16847
  • Haut SR, Nabbout R. Recognizing seizure clusters in the community: the path to uniformity and individualization in nomenclature and definition. Epilepsia. 2022;63(suppl):S6–S13. doi:10.1111/epi.17346
  • Cereghino JJ, Mitchell WG, Murphy J, Kriel RL, Rosenfeld WE, Trevathan E. Treating repetitive seizures with a rectal diazepam formulation: a randomized study. The North American diastat study group. Neurology. 1998;51(5):1274–1282. doi:10.1212/WNL.51.5.1274
  • Mitchell WG, Conry JA, Crumrine PK, et al. An open-label study of repeated use of diazepam rectal gel (Diastat) for episodes of acute breakthrough seizures and clusters: safety, efficacy, and tolerance. North American Diastat Group Epilepsia. 1999;40(11):1610–1617.
  • Hua S. Physiological and pharmaceutical considerations for rectal drug formulations. Front Pharmacol. 2019;10:1196.
  • Bausch Health US, LLC. Diastat® C-IV (Diazepam Rectal Gel) [Prescribing Information]. Bridgewater, NJ: Bausch Health US, LLC; 2023.
  • Penovich P, Wheless JW, Hogan RE, et al. Examining the patient and caregiver experience with diazepam nasal spray for seizure clusters: results from an exit survey of a phase 3, open-label, repeat-dose safety study. Epilepsy Behav. 2021;121(Pt A):108013. doi:10.1016/j.yebeh.2021.108013
  • Meng TC, Szaflarski JP, Chen L, et al. Psychosocial outcomes of repeated treatment of seizure clusters with midazolam nasal spray: results of a phase 3, open-label extension trial. Epilepsy Behav. 2023;138:108989. doi:10.1016/j.yebeh.2022.108989
  • Dean P, O’Hara K, Brooks L, Shinnar R, Bougher G, Santilli N. Managing acute seizures: new rescue delivery option and resources to assist school nurses. NASN Sch Nurse. 2021;36(6):346–354. doi:10.1177/1942602X211026333
  • Neurelis, Inc. VALTOCO® (Diazepam Nasal Spray) [Prescribing Information]. San Diego, CA: Neurelis, Inc.; 2023.
  • UCB, Inc. Nayzilam® (Midazolam Nasal Spray) [Prescribing Information]. Smyrna, GA: UCB, Inc.; 2023.
  • Wheless JW, Miller I, Hogan RE, et al. Final results from a phase 3, long-term, open-label, repeat-dose safety study of diazepam nasal spray for seizure clusters in patients with epilepsy. Epilepsia. 2021;62(10):2485–2495. doi:10.1111/epi.17041
  • Hogan RE, Gidal BE, Koplowitz B, Koplowitz LP, Lowenthal RE, Carrazana E. Bioavailability and safety of diazepam intranasal solution compared to oral and rectal diazepam in healthy volunteers. Epilepsia. 2020;61(3):455–464. doi:10.1111/epi.16449
  • Detyniecki K, Van Ess PJ, Sequeira DJ, Wheless JW, Meng TC, Pullman WE. Safety and efficacy of midazolam nasal spray in the outpatient treatment of patients with seizure clusters-A randomized, double-blind, placebo-controlled trial. Epilepsia. 2019;60(9):1797–1808. doi:10.1111/epi.15159
  • Wheless JW, Meng TC, Van Ess PJ, Detyniecki K, Sequeira DJ, Pullman WE. Safety and efficacy of midazolam nasal spray in the outpatient treatment of patients with seizure clusters: an open-label extension trial. Epilepsia. 2019;60(9):1809–1819. doi:10.1111/epi.16300
  • Rabinowicz AL, Faught E, Cook DF, Carrazana E. Implications of seizure-cluster treatment on healthcare utilization: use of approved rescue medications. Neuropsychiatr Dis Treat. 2022;18:2431–2441. doi:10.2147/NDT.S376104
  • Faught E. Economic aspects of treating seizure clusters. Epilepsia. 2022;63(suppl 1):S45–54. doi:10.1111/epi.17340
  • Tarquinio D, Dlugos D, Wheless JW, Desai J, Carrazana E, Rabinowicz AL. Safety of diazepam nasal spray in children and adolescents with epilepsy: results from a long-term phase 3 safety study. Pediatr Neurol. 2022;132:50–55. doi:10.1016/j.pediatrneurol.2022.04.011
  • Peters JM, Puri V, Segal E, Misra SN, Rabinowicz AL, Carrazana E. Concomitant cannabidiol does not impact safety and effectiveness of diazepam nasal spray for seizure clusters: post hoc analysis of a phase 3 safety study. Epilepsy Behav. 2023;144:109248. doi:10.1016/j.yebeh.2023.109248
  • Segal EB, Tarquinio D, Miller I, et al. Evaluation of diazepam nasal spray in patients with epilepsy concomitantly using maintenance benzodiazepines: an interim subgroup analysis from a phase 3, long-term, open-label safety study. Epilepsia. 2021;62(6):1442–1450. doi:10.1111/epi.16901
  • Vazquez B, Wheless J, Desai J, Rabinowicz AL, Carrazana E. Lack of observed impact of history or concomitant treatment of seasonal allergies or rhinitis on repeated doses of diazepam nasal spray administered per seizure episode in a day, safety, and tolerability: interim results from a phase 3, open-label, 12-month repeat-dose safety study. Epilepsy Behav. 2021;118:107898. doi:10.1016/j.yebeh.2021.107898
  • Miller I, Wheless JW, Hogan RE, et al. Consistent safety and tolerability of Valtoco® (diazepam nasal spray) in relationship to usage frequency in patients with seizure clusters: interim results from a phase 3, long-term, open-label, repeat-dose safety study. Epilepsia Open. 2021;6(3):504–512. doi:10.1002/epi4.12494
  • Cook DF, Gustin RM, Misra SN, et al. Effectiveness of diazepam nasal spray does not vary across times of day associated with meals and fasting in patients with seizure clusters: post hoc results from a long-term, open-label safety study. Nashville, TN: Presented at: AES; 2022.
  • Cramer JA, Faught E, Davis C, Misra SN, Carrazana E, Rabinowicz AL. Quality-of-life results in adults with epilepsy using diazepam nasal spray for seizure clusters from a long-term, open-label safety study. Epilepsy Behav. 2022;134:108811. doi:10.1016/j.yebeh.2022.108811
  • Misra SN, Sperling MR, Rao VR, et al. Significant improvements in SEIzure interVAL (time between seizure clusters) across time in patients treated with diazepam nasal spray as intermittent rescue therapy for seizure clusters. Epilepsia. 2022;63(10):2684–2693. doi:10.1111/epi.17385
  • O’Hara K, Dewar S, Bougher G, Dean P, Misra SN, Desai J. Overcoming barriers to the management of seizure clusters: ease of use and time to administration of rescue medications. Expert Rev Neurother. 2023;23(5):425–432. doi:10.1080/14737175.2023.2206568
  • Chhabra R, Gupta R, Gupta LK. Intranasal midazolam versus intravenous/rectal benzodiazepines for acute seizure control in children: a systematic review and meta-analysis. Epilepsy Behav. 2021;125:108390. doi:10.1016/j.yebeh.2021.108390
  • Nunley S, Glynn P, Rust S, Vidaurre J, Albert DVF, Patel AD. A hospital-based study on caregiver preferences on acute seizure rescue medications in pediatric patients with epilepsy: intranasal midazolam versus rectal diazepam. Epilepsy Behav. 2019;92:53–56. doi:10.1016/j.yebeh.2018.12.007
  • Knoester PD, Jonker DM, Van Der Hoeven RT, et al. Pharmacokinetics and pharmacodynamics of midazolam administered as a concentrated intranasal spray. A study in healthy volunteers. Br J Clin Pharmacol. 2002;53(5):501–507. doi:10.1046/j.1365-2125.2002.01588.x
  • de Haan GJ, van der Geest P, Doelman G, Bertram E, Edelbroek P. A comparison of midazolam nasal spray and diazepam rectal solution for the residential treatment of seizure exacerbations. Epilepsia. 2010;51(3):478–482. doi:10.1111/j.1528-1167.2009.02333.x
  • ClinicalTrials.gov. Pharmacokinetics study of VALTOCO® in pediatric subjects with epilepsy (NCT05076838). Available from: https://clinicaltrials.gov/ct2/show/NCT05076838. Accessed August 16, 2022.