Successful administration of neffy (epinephrine nasal spray) by patients and caregivers - Five human factor studies

Delayed or incorrect administration of epinephrine during anaphylaxis is common and is often attributable to fear of needles, lack of training, and device complexity. Epinephrine nasal spray (neffy) was developed as a needle-free alternative intended for use by patients, caregivers, and bystanders in community settings.

To evaluate and establish whether neffy device can be safely and effectively administered by intended users in simulated emergency settings using its Instructions for Use (IFU), Quick Reference Guide (QRG), and optional carrying case.

Five human factors (HF) studies were conducted in 204 subjects, including adult and adolescent allergy patients, caregivers, healthcare professionals, and passers-by. Studies included one formative study, one validation study, one bridging validation study, and two post-validation supplemental studies assessing updated labeling and an optional carrying case. Subjects were untrained unless otherwise specified and completed simulated anaphylaxis scenarios involving single and repeated dosing. Use success, errors, and comprehension of critical tasks were assessed. All devices were air-filled only and did not contain epinephrine.

Across validation and post-validation studies, all subjects successfully administered single and repeated doses from the air-filled neffy device using only the device and QRG. Minor, no-harm use issues were observed in earlier studies and were addressed through iterative refinements to labeling. No unanticipated use issues were identified with the optional carrying case.

These HF studies demonstrate that iterative development and validation of the IFU and QRG resulted in instructions that support reliable and correct administration of neffy across diverse user populations, including adolescents and untrained bystanders. The final FDA-approved labeling was used successfully without dosing errors and supports safe, effective, and repeat administration of intranasal epinephrine in emergency settings.