Neffy nasal spray effective in treating anaphylaxis symptoms in real-world study.

ALK has announced real-world evidence evaluating the effectiveness of nasal adrenaline spray neffy in treating anaphylaxis symptoms during oral food challenge and allergen immunotherapy. The study found that 89.2% of 545 patients were successfully treated with a single dose, while 10.8% required a second dose. The results suggest that neffy is effective in treating anaphylaxis symptoms in real-world clinical practice, consistent with historic response rates observed with adrenaline injectors.

ALK (ALKB:DC / OMX: ALK B) has announced that real-world evidence evaluating the clinical performance of the nasal adrenaline spray neffy® in US patients experiencing anaphylaxis symptoms during oral food challenge and allergen immunotherapy has been accepted for scientific publication. The findings, published in the Annals of Allergy, Asthma and Immunology, represent the first large-scale analysis of treatment outcomes with neffy® during routine clinical practice [1].

The study found that 89.2% of 545 patients were successfully treated with a single dose of neffy® by a healthcare provider, while 10.8% required a second dose. These results suggest that neffy® is effective in treating anaphylaxis symptoms in real-world clinical practice, consistent with historic response rates observed with adrenaline injectors, which report a similar proportion of patients being successfully treated with a single dose [2].

Neffy® is a needle-free nasal adrenaline spray developed by US-based ARS Pharmaceuticals, Inc. ALK holds exclusive global rights to commercialize neffy®, with the exception of the USA, Australia, New Zealand, Japan, and China. The EURneffy® nasal adrenaline spray was launched in Germany in June 2025, with additional launches planned before year-end [1].

The observational analysis was based on data collected from healthcare providers participating in the neffy® experience program. Healthcare providers were given six doses of neffy® for use to rescue patients experiencing anaphylaxis symptoms during oral food challenge or allergen immunotherapy. neffy® US labeling states that a second dose should be administered if anaphylaxis symptoms continue or get worse starting 5 minutes after the first dose. As of the March 2025 data cut-off, 301 healthcare providers had responded to the survey instrument, and a total of 545 patients were reported having been treated with neffy® 2 mg [1].

These real-world data build upon previously published clinical evidence, including a prospective Phase 3 study assessing the efficacy of neffy® for the treatment of oral food challenge-induced anaphylaxis symptoms, which found no patients requiring a second dose of neffy® for treatment of the initial anaphylactic reaction [2].

The neffy® experience program is actively ongoing and now includes both the 2 mg and 1 mg doses. The data from this retrospective observational analysis differ from a randomized clinical trial in several ways, including different endpoints and inherent limitations in real-world observational studies [2].

Neffy® is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adults and children aged 4 years and older who weigh 33 lbs. or greater. The spray contains epinephrine, a medicine used to treat allergic emergencies, and is for use in the nose only. Each neffy® contains a single dose of epinephrine, and a second dose should be administered if symptoms continue or get worse after the first dose [2].

References:
[1] https://www.globenewswire.com/news-release/2025/09/08/3146071/0/en/Real-world-evidence-supports-clinical-effectiveness-of-the-neffy-nasal-adrenaline-spray.html
[2] https://www.morningstar.com/news/globe-newswire/9524515/real-world-evidence-supports-clinical-effectiveness-of-neffy-epinephrine-nasal-spray-in-patients-experiencing-anaphylaxis