11 Sep Real World Study Finds Neffy Epinephrine Spray Can Effectively Treat Acute Allergic Reactions, Earns FDA Approval

MedicalResearch.com Interview with:

Dr. Casale

Thomas B. Casale, M.D.
Professor of Medicine and Pediatrics
Chief of Clinical and Translational Research
Division of Allergy and Immunology
USF Health Morsani College of Medicine
University of South Florida
Tampa, Florida

MedicalResearch.com: What is the background for this study?

Response: The data leading to FDA approval of neffy came from extensive pharmacokinetic and pharmacodynamic studies. As with previous epinephrine delivery devices, the FDA asked for data showing that after delivery of neffy the epinephrine blood levels and expected changes in pulse and blood pressure were similar to those achieved with injectable formulations of epinephrine. neffy performed as expected with blood levels of epinephrine bracketed by those achieved with EpiPen and a needle and syringe along with increases in pulse and blood pressure compatible with the epinephrine levels measured.

Additionally, clinicians are interested in whether neffy would perform similarly in real clinical situations. The data from the neffy experience program provides real-world assurance that neffy can effectively treat acute allergic reactions. Given the large number of patients and the similar findings to those achieved with injectable epinephrine in previous studies, the data should provide assurance that neffy can be an effective substitute for injectable epinephrine in patients that desire a needle-free option.

How does neffy® differ from other medications for anaphylaxis?

Response:  Many adults and children fear needles, leading many to delay administering auto-injector epinephrine treatments, which can lead to the progression of life-threatening anaphylaxis. neffy is a needle-free nasal spray that patients and their caregivers can use at the first sign of symptoms, without the risk of accidental injections into the hands or fingers, which occur about 3,500 times each year.

Patients like the small size of neffy as it can fit into your pocket, is temperature stable up to 122°F and has a long shelf life of 24-30 months based on the dose.

MedicalResearch.com: What are the main findings?

Response:  The data leading to FDA approval of neffy came from extensive pharmacokinetic and pharmacodynamic studies. As with previous epinephrine delivery devices, the FDA asked for data showing that after delivery of neffy the epinephrine blood levels and expected changes in pulse and blood pressure were similar to those achieved with injectable formulations of epinephrine. neffy performed as expected with blood levels of epinephrine bracketed by those achieved with EpiPen and a needle and syringe along with increases in pulse and blood pressure compatible with the epinephrine levels measured.

Additionally, clinicians are interested in whether neffy would perform similarly in real clinical situations. The data from the neffy experience program provides real-world assurance that neffy can effectively treat acute allergic reactions. Given the large number of patients and the similar findings to those achieved with injectable epinephrine in previous studies, the data should provide assurance that neffy can be an effective substitute for injectable epinephrine in patients that desire a needle-free option.

MedicalResearch.com: How does neffy® differ from other medications for anaphylaxis?

Many adults and children fear needles, leading many to delay administering auto-injector epinephrine treatments, which can lead to the progression of life-threatening anaphylaxis. neffy is a needle-free nasal spray that patients and their caregivers can use at the first sign of symptoms, without the risk of accidental injections into the hands or fingers, which occur about 3,500 times each year.

Patients like the small size of neffy as it can fit into your pocket, is temperature stable up to 122°F and has a long shelf life of 24-30 months based on the dose.

MedicalResearch.com:  Might more than one dose be successful in the 10% of non-responders?

Response:  Of the 545 patients treated with neffy as part of the neffy experience program, 59 patients required a second dose of treatment. 

MedicalResearch.com: What should readers take away from your report?

Response: This is the first large-scale report of real-world treatment outcomes with neffy during anaphylaxis events, which reinforces existing findings and shows virtually identical response rates to epinephrine injection, thus demonstrating the clinical interchangeability of neffy and epinephrine injection.

These findings along with the ease of administration, small size, temperature stability and long shelf life, offer patients a treatment option they will carry and use.

MedicalResearch.com: Is there anything else you would like to add? Any disclosures?

Response: We have learned that most patients do not fill prescriptions for injectable epinephrine, and those who do often do not carry or appropriately use them, delaying epinephrine administration. Providing an easier-to-carry, needle-free option, like neffy, is a step forward in managing severe allergic reactions. Self-management by patients and administration to young children by parents and caregivers is easy with neffy, which translates to less visits to hospital emergency rooms and ultimately the potential to save lives.

Disclosures: Dr. Casale is a member of the ARS Pharma’s scientific advisory board.

Citations:

1 Patel N, Chong KW, Yip AYG, Ierodiakonou D, Barta J, Boyle RJ, et al. Use of multiple epinephrine doses in anaphylaxis: a systematic review and meta-analysis. J Allergy Clin Immunol. 2021;148(5):1307-1315.

2 Ebisawa M, Takahashi K, Takahashi KK, Yanagida N, Sato S, Lieberman J, et al. Epinephrine nasal spray improves allergic symptoms in patients undergoing oral food challenge, phase 3 trial. J Allergy Clin Immunol. 2025; doi:10.1016/j.jaip.2025.06.038.

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Last Updated on September 11, 2025 by Marie Benz MD FAAD