Human Factors MD tested newly FDA approved neffy® epinephrine nasal spray

Christina C. Mendat, PhD, Managing Director, Eurofins Human Factors MD

In August 2024, the U.S. Food and Drug Administration (FDA) approved ARS Pharmaceuticals neffy^® (epinephrine nasal spray) for the emergency treatment of Type I allergic reactions, including life-threatening anaphylaxis, in adults and pediatric patients weighing at least 30 kilograms (about 66 pounds).

Eurofins Human Factors MD is proud to have played a key role in this impactful program by conducting three supplemental human factors validation studies with a total of 92 participants. These tests, which focused on product use, labeling, and packaging, demonstrated that neffy^® is safe and effective for both experienced and novice users, including children as young as 10 years old. The studies confirmed that users can administer the spray without training, either on themselves or others, even in the event of worsening
symptoms.

According to an FDA press release, “The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis. As a result, neffy^® provides an important treatment option and addresses an unmet need,” said Kelly Stone, MD, PhD, Associate Director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research. This approval marks the first major innovation in epinephrine delivery in over 35 years and establishes neffy^® as the first and only needle-free
option for patients and families managing severe allergic reactions.

Additionally, ARS Pharmaceuticals developed a portable carrying case, which underwent its own human factors testing to ensure users can quickly access neffy^® while keeping the product secure and intact.

To find out more about how Eurofins Human Factors MD can solve your testing challenges, visit: www.eurofins.com/medical-device/human-factors-testing/

ARS Pharmaceuticals Press Release