References
- Chen Z, Brodie MJ, Liew D, et al. Treatment outcomes in patients with newly diagnosed epilepsy treated with established and new antiepileptic drugs. JAMA Neurol. 2018;75:279–286.
- Jafarpour S, Hirsch LJ, Gainza-Lein M, et al. Seizure cluster: definition, prevalence, consequences, and management. Seizure. 2019;68:9–15.
- Maglalang PD, Rautiola D, Siegel RA, et al. Rescue therapies for seizures emergencies: new modes of administration. Epilepsia. 2018;59(Suppl 2):207–215.
- Cloyd J, Haut S, Carrazana E, et al. Overcoming the challenges of developing intranasal diazepam rescue therapy for the treatment of seizure clusters. Epilepsia. 2021; 00:1–11.
- Agarwal SK, Cloyd JC. Development of benzodiazepines for out-of-hospital management of seizure emergencies. Neurol Clin Pract. 2015;5(1):80–85.
- Mula M. New non-intravenous routes for benzodiazepines in epilepsy: a clinician perspective. CNS Drugs. 2017;31(1):11–17.
- Tatum WO. Adult patient perceptions of emergency rectal medications for refractory seizures. Epilepsy Behav. 2002;3(6):535–538.
- Agarwal SK, Kriel RL, Brundage RC, et al. A pilot study assessing the bioavailability and pharmacokinetics of diazepam after intranasal and intravenous administration in healthy volunteers. Epilepsy Res. 2013;105(3):362–367.
- Kriel RL, Cloyd JC, Hadsall RS, et al. Home use of rectal diazepam for cluster and prolonged seizures: efficacy, adverse reactions, quality of life, and cost analysis. Pediatr Neurol. 1991;7:13–17.
- Meyer J, Quenzer L Psychopharmacology drugs, the brain and behavior. Sunderland, MA: Sinauer Associates, Inc; 2005. Chapter 7 179-180, Chapter 17; p. 423–424.
- Greenfield LJ, Sahaya K, Shihabuddin B, et al. Wyllie’s Treatment of Epilepsy Sixth Edition. Wolters Kluwer- Philadelphia, Baltimore, New York, London, Hong Kong, Buenos Aires, Sydney, Tokyo. Chapter 50. 594. 2011.
- Kay L, von Blomberg A, Willems LM, et al. Intranasal midazolam as first‐line inhospital treatment for status epilepticus: a pharmaco‐EEG cohort study. Ann Clin Transl Neurol. 2019;6:2413–2425.
- Wang Z, Xiong G, Tsang WC, et al. Nose-to-brain delivery. J Pharmaco Exp Ther. 2019;370(3):593–601.
- Vazquez B, Wheless J, Desai J, et al. Lack of observed impact of history or concomitant treatment of seasonal allergies or rhinitis on repeat 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 study. Epilepsy Behav. 2021 May;118:107898.
- Cereghino JJ, Mitchell WG, Murphy J, et al. The North American diastat study group. Treating repetitive seizures with a rectal diazepam formulation a randomized study. Neurology. 1998;51(5):1274–1281.
- Sperling MR, Haas KF, Krauss G, et al. Dosing feasibility and tolerability of intranasal diazepam in adults with epilepsy. Epilepsia. 2014;55:1544–1550.
- Hogan RE, Gidal BE, Koplowitz B, et al. Bioavailability and safety of diazepam intranasal solution compared to oral and rectal diazepam in healthy volunteers. Epilepsia. 2020;61:455–464.
- Tanimoto S, Pesco Koplowitz L, Lowenthal RE, et al. Evaluation of pharmacokinetics and dose proportionality of diazepam after intranasal administration of NRL-1 to healthy volunteers. Clin Pharmacol Drug Dev. 2020;9(6):719–727.
- Hogan RE, Tarquinio D, Sperling MR, et al. Pharmacokinetics and safety of VALTOCO (NRL-1; diazepam nasal spray) in patients with epilepsy during a seizure (ictal/peri-ictal) and nonseizure (inter-ictal) conditions: a phase 1, open-label study. Epilepsia. 2020;61(5):935–943.
- Neurelis, Inc. Valtoco (diazepam nasal spray), full prescribing information. San Diego, CA: Neurelis Inc; 2021.
- Miller I, Wheless J, Sperling M, 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;00:1–9.
- 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;00:1–9.
- Wheless JW. A critical evaluation of midazolam nasal spray for the treatment of patients with seizure clusters. Expert Rev Neurother. 2021 Mar;12:1–11.