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Edwards ET, Edwards ES, Davis E, et al. Comparative Usability Study of a Novel Auto-Injector and an Intranasal System for Naloxone Delivery. Pain Ther. 2015;4(1):89-105doi: 10.1007/s40122-015-0035-9.
Edwards, E. T., Edwards, E. S., Davis, E., Mulcare, M., Wiklund, M., & Kelley, G. (2015). Comparative Usability Study of a Novel Auto-Injector and an Intranasal System for Naloxone Delivery. Pain and therapy, 4(1), 89-105. https://doi.org/10.1007/s40122-015-0035-9
Edwards, Evan T, et al. "Comparative Usability Study of a Novel Auto-Injector and an Intranasal System for Naloxone Delivery." Pain and therapy vol. 4,1 (2015): 89-105. doi: https://doi.org/10.1007/s40122-015-0035-9
Edwards ET, Edwards ES, Davis E, Mulcare M, Wiklund M, Kelley G. Comparative Usability Study of a Novel Auto-Injector and an Intranasal System for Naloxone Delivery. Pain Ther. 2015 Jun;4(1):89-105. doi: 10.1007/s40122-015-0035-9. Epub 2015 Apr 25. PMID: 25910473; PMCID: PMC4470965.
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Pain Ther. 2015 Jun;4(1):89-105. doi: 10.1007/s40122-015-0035-9. Epub 2015 Apr 25.

Comparative Usability Study of a Novel Auto-Injector and an Intranasal System for Naloxone Delivery.

Pain and therapy

Evan T Edwards, Eric S Edwards, Erin Davis, Maureen Mulcare, Michael Wiklund, Glen Kelley

Affiliations

  1. kaleo, Inc., Richmond, VA, USA, [email protected].

PMID: 25910473 PMCID: PMC4470965 DOI: 10.1007/s40122-015-0035-9

Abstract

INTRODUCTION: The standard of care for reversal of opioid-induced respiratory depression associated with opioid overdose is injectable naloxone. This study compared the usability of two naloxone delivery devices, a naloxone auto-injector (NAI) and a naloxone intranasal delivery system (NXN), in the administration of naloxone during a simulated opioid overdose emergency. NAI (EVZIO (®) ; kaleo, Inc., Richmond, VA, USA) is a Food and Drug Administration approved single-use pre-filled auto-injector containing 0.4 mg of naloxone.

METHODS: Study participants were randomly assigned to administer naloxone using NAI and NXN, sequentially. The primary endpoint was successful administration of a simulated dose of naloxone into a mannequin during a simulated opioid emergency, both before and after receiving training. Secondary endpoints included using the NAI or NXN in accordance with the instructions-for-use and the comparative measurement of successful completion time of administration for both NAI and NXN.

RESULTS: A total of 42 healthy participants aged 18-65 years were enrolled in the study. The proportion of participants able to successfully administer a simulated dose of naloxone was significantly greater for NAI compared to NXN both before (90.5% vs. 0.0%, respectively, P < 0.0001) and after (100% vs. 57.1%, respectively, P < 0.0001) participant training. The proportion of participants able to administer a simulated dose of naloxone in accordance with the instructions-for-use was also significantly greater for NAI compared to NXN before (85.7% vs. 0.0%, respectively, P < 0.0001) and after (100% vs. 0.0%, respectively, P < 0.0001) participant training. The average time to task completion for administration attempt before training was 0.9 ± 0.25 min for NAI versus 6.0 ± 4.76 min for NXN and after training was 0.5 ± 0.15 min for NAI versus 2.0 ± 2.15 min for NXN.

CONCLUSION: Laypersons experienced substantially greater success administering a simulated dose of naloxone, both before and after training, using NAI versus NXN during a simulated opioid overdose emergency. No participants correctly used NXN without training.

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