P4.A017: neffy, nasal epinephrine sprayer, demonstrated successful use by patients and caregivers: Human Factor Findings

Background: ARS has been developing neffy, an intranasal epinephrine sprayer, for the indicationof severe allergic reactions including anaphylaxis. Since severe allergic reactions often occur out of a hospital setting and epinephrine is administered by patients or caregivers, human factor (HF) studies are required to evaluate the user interface of products. For neffy, four HF studies were conducted.

Methods: The first two studies included a Formative study (n=22; untrained) with 8 adult allergy patients who had been prescribed epinephrine, 8 caregivers who would be willing to administer medication and 6 medical professionals. The Primary HF Validation study (n=90; untrained) included 15 adult and 15 adolescent allergy patients that were experienced with epinephrine products, 15 adult and 15 adolescent allergy patients that were naïve to epinephrine products, 15 naïve passer-byes and 15 medical professionals. After modifications to the Instructions for Use (IFU) and Quick Reference Guide (QRG) were made to specify the dosing method and improve images, a Bridging HF Validation Study was conducted with 60 subjects (untrained and trained): 15 untrained naïve adult patients, 15 untrained adult naïve caregivers, 15 untrained adolescents, and 15 trained adolescents. Following further modification that are specific to the administration of the second dose in the same nostril, Supplemental HF Validation studies were conducted in a total of 16 subjects (untrained); 4 naïve adult patients, 4 naïve adult caregivers, and 8 naïve adolescent patients. All adolescent participants aged from 10 to 17 years.

Results: In all four studies and across all tasks and user groups, subjects administered neffy 98% of the time without user error, both on single (n=188) and repeat dosing (n=161). In one study (Bridging HF Validation Study) untrained adolescents had 3 use errors with the first dose and 3 with the second dose, all related to inserting the tip fully and keeping the sprayer straight when fired. In the Supplemental study (n=16; untrained) with the final labeling recommending that the second dose be administered to the same nostril, 100% of adults and 100% of adolescent patients were able to dose both the first and second doses of neffy in the same nostril during a simulated severe allergic reaction without any use errors.

Conclusion: The intended users include adults and children 10-17 years old with severe food allergy patients. Caregivers demonstrated that they were able to administer neffy safely and successfully both once and twice during a simulated allergy emergency, including dosing themselves or a simulated patient. Based on the final intended labeling there were no use errors. Given neffy utilizes the same over-the-counter device as Narcan, we anticipate ease of use and minimal risk of user errors.