Howard LeWine, M.D., “Quick Injection Helps Stop Epileptic Seizures,” Harvard Health Blog, Feb. 23, 2012; p. 1 “Managing Epilepsy Well Network and Selected Self-Management Programs; Putting Collective Wisdom to Work for People with Epilepsy,” Prevention Research Centers (PRC), CDC , Nov. 2016, pp.1-17 K.M.
Fiest, et al., “Prevalence and Incidence of Epilepsy, A Systematic Review and Meta-Analysis of International Studies,” NEUROLOGY 88, Jan. 17, 2017, pp.296-303 SIGMA Chemical Company Catalog (1988) E. Bechgaard et al., “Solubilization of Various Benzodiazepines for Intranasal Administration, A Pilot Study,” Pharmaceutical Development and Technology 2:293-296 (1997) A. Hussain et al. “Nasal Absorption of Propranolol in Humans,” Journal of Pharmaceutical Sciences 69:1240 (1980) S. Lau and J. Slattery, “Absorption of Diazepam and Lorazepam Following Intranasal Administration,” International Journal of Pharmaceutics, 54:171-174 (1989) M. Schols-Hendriks et al., “Absorption of Clonazepam After Intranasal and Buccal Administration,” British Journal of Clinical Pharmacology 39:449-451 (1995) 2011 Dr. Nicholas Peppas Deposition Transcript, October 24, 2019.
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 Declaration of Dr. Sveinbjorn Gizurarson, Ph.D. J. Riss et al., “Benzodiazepines in Epilepsy: Pharmacology and Pharmacokinetics,” Acta Neurologica Scandinavica 118:69-86 (2008) D. Wermeling, U.S. Patent No. 6,610,271, issued August 26, 2003 C. Cole et al., “Community Survey of Carer’s: Individual Epilepsy Guidelines (IEG) for Rescue Medication,” Seizure 18:220-224 (2009) D. Terry et al., “Acceptance of the Use of Diazepam Rectal Gel in School and Day Care Settings,” Journal of Child Neurology 22:1135- 1138 (2007) Diastat® Label (2005) “UCB announces NAYZILAM® (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the U.S.,” UCB Press Release, https://www.biospace.com/article/releases/ucb- announces-nayzilam-midazolam-nasal-spray-now-approved-by-fda- to-treat-intermittent-stereotypic-episodes-of-frequent-seizure-activity- in-people-living-with-epilepsy-in-the-u-s-/ (2019) (Accessed October 31, 2019) J. French and T. Pedley, “Initial Management of Epilepsy,” New England Journal of Medicine 359:166-176 (2008) G. Corbo et al. “Measurement of Nasal Mucociliary Clearance,” Archives of Disease in Childhood 64:546-550 (1989) “How does the nose work?
The nasal mucosa,” https://www.fitonasal2act.com/how-does-the-nose-work/the-nasal- mucosa/ (Accessed November 5, 2019) N. Mygind, “Nasal Allergy,” 9 (Blackwell Scientific Publications, 1979) “Neurelis Files New Drug Application With The FDA For VALTOCO™ (Diazepam Nasal Spray), An Investigational Treatment For Pediatric, Adolescent And Adult Epilepsy Patients,” 2024 2025 2026 2027 2028 2029 2030 2031 https://www.neurelis.com/neurelis-news/neurelis-files-new-drug- application-fda-valtocotm-nasal-spray-investigational-treatment- pediatric (2018) (Accessed November 1, 2019) “Neurelis Receives FDA Orphan Drug Designation for NRL-1 in the Treatment of Acute Repetitive Seizures,” https://www.neurelis.com/neurelis-news/fda-orphan-drug-designation (2015) (Accessed November 1, 2019) Affidavit of Robert Cleary (Dated November 21, 2019) [SERVED
Licenses Aegis Therapeutics' Intravail Drug Delivery Technology” (Business Wire) (April 13, 2005) Handbook of Pharmaceutical Excipients (Pharmaceutical Press and American Pharmacists Association, Publishers) (Fifth Edition, 2006) J. Wyse, U.S. Patent No. 9,192,570 issued November 24, 2015 Daniel P. Wermeling Deposition Transcript, February 26, 2020