BSACI EURneffy Statement
The BSACI is pleased to release today an updated statement on EURneffy. This replaces the one released shortly after the MHRA approval of EURneffy in July 2025, and reflects the recent publication of data from the USA relating to clinical use. The statement has also been amended to make clearer reference to all age groups.
The BSACI welcomes the recent approval by the MHRA of EURneffy, an intranasal device to administer adrenaline for the emergency treatment of anaphylaxis1. Patients are often reluctant to use or carry injected adrenaline. This can delay treatment and increase the risk of severe outcomes. The availability of a more compact, needle-free device is likely to reduce the reluctance of patients and others to use and carry adrenaline. This should result in more timely treatment of reactions.
At the present time, the BSACI recommends shared decision-making when counselling patients on the use of EURneffy in place of injectable adrenaline. This should outline the potential advantages as well as some of the differences (see table below). Patients should continue to have an Allergy Action Plan2 to guide treatment and should always call emergency services (999 in the UK) after using any adrenaline for anaphylaxis – irrespective of whether this has been given using EURneffy or by intramuscular (IM) injection. Paramedics and Emergency Departments should continue to have IM adrenaline available for treating anaphylaxis (in line with guidelines from the Resuscitation Council UK).3
The approval of EURneffy in USA, Europe and now the UK was based on dosing with EURneffy resulting in similar blood levels of adrenaline to that seen with IM adrenaline injection, and similar (but not identical) changes in blood pressure and heart rate (something referred to as bioequivalence).1, 4, 5 BSACI notes that bioequivalence data (blood adrenaline levels and blood pressure) are not replacements for controlled clinical efficacy data.6,7 The adrenaline autoinjectors in current use were also approved without randomised controlled studies. Data relating to the effectiveness for EURneffy are limited to the following real-world data:
- A report of 15 children reacting at food challenge, 8 of whom had anaphylaxis (WAO definition).8
- An uncontrolled case series of 545 patients (age range not specified) having allergic symptoms during oral food challenge or allergen immunotherapy, reported in a press release from the manufacturer dated 8th September 2025.9 Four hundred and eighty-six (486, or 89%) of 545 patients were effectively treated with a single dose of EURneffy, although it is not clear what proportion of these were having anaphylaxis according to the WAO or UK definitions.
BSACI is reassured by these new data that for most patients at risk of anaphylaxis, EURneffy can be considered to be suitable means of giving rescue adrenaline to treat anaphylaxis.
With the current evidence, however, our view is that EURneffy has not yet been shown to be as effective as IM adrenaline in treating anaphylaxis for some patient groups, including:
- people who have previously needed more than 1 dose of adrenaline to treat anaphylaxis
- people with a previous severe anaphylaxis with hypotension, something which is more common in those with allergy to insect venom.
At the present time, we do not recommend EURneffy as the sole rescue therapy for patients in these two groups and advise that these patients should continue to have ongoing access to adrenaline autoinjectors. They could be prescribed EURneffy for use in the first instance. We welcome ongoing activities to collect data relating to clinical efficacy and real-world effectiveness relating to EURneffy within established networks.
For all other patients at risk of anaphylaxis, we welcome the availability of EURneffy and, in due course, other non-injectable forms of adrenaline. We look forward to the publication of further data on clinical effectiveness in patients having anaphylaxis, to support the widespread adoption of non-injectable forms of adrenaline through shared decision making.
| Adrenaline autoinjectors | EURneffy |
| Historical approval | Approval based on bioequivalence |
| Established route of administration, intramuscular injection | New, intranasal route of administration |
| Over 40 years of clinical experience | New, very limited clinical experience |
| Less compact, not easily carried | More compact, easily carried |
| Self-administered injection | Needle-free |
Click here to view a PDF of the statement.
References
1 https://www.gov.uk/government/news/mhra-approves-adrenaline-nasal-spray-the-first-needle-free- emerg…
2 https://www.bsaci.org/resources/allergy-action-plans/
3 https://www.resus.org.uk/library/additional-guidance/guidance-anaphylaxis/emergency-treatment
4 https://www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment- anaphy…
5 https://www.ema.europa.eu/en/medicines/human/EPAR/eurneffy
6 Patel et al. J Allergy Clin Immunol. 2025 Feb;155(2):418-420. doi: 10.1016/j.jaci.2024.10.026.
7 Dribin et al. J Allergy Clin Immunol. 2025 Aug 26. doi: 10.1016/j.jaci.2025.07.023.
8 Ebisawa et al. J Allergy Clin Immunol. Pract 2025; doi: 10.1016/j.jaip.2025.06.038.
9 ARS. Real-World Evidence Supports Clinical Effectiveness of neffy® (epinephrine nasal spray) in Patients Experiencing Anaphylaxis. Press release September 8, 2025. Available at: https://ir.ars- pharma.com/news-releases/news-release-details/real-world-evidence-supports-clinical-…