Neffy has been described as the “world’s first needle-free alternative” to injectable adrenaline, used as a first-line treatment for allergic reactions, including anaphylaxis. On 9 August 2024, following Neffy’s long-anticipated approval by the U.S. Food and Drug Administration, Richard Lowenthal of ARS Pharmaceuticals (a biopharmaceutical company which invented Neffy) said:
“This approval marks a watershed moment in addressing an unmet medical need for people with Type I allergies – a treatment alternative that avoids the need to inject epinephrine with a needle, which can be fraught with anxiety and fear for many.”
Dr Douglas Jones MD, American Board certified allergist and immunologist and President of FAST OIT (American association of physicians offering oral immunotherapy for food allergies) observed:
“This is a game changer because a major barrier to patients treating significant allergic reactions with epinephrine is the fear of needles. This often leads to a delay in appropriate treatment or it not being administered at all. Having a non-needle option will hopefully open the doors for people to do as we have been asking all along: Epi first and Epi fast.”
Dr Adam Fox MD, Professor of Paediatric Allergy and former President of the British Society of Allergy & Clinical Immunology, said:
“Neffy has a potential to reduce a lot of anxiety amongst patients who are needlephobic and worry about having to injectable adrenaline. …We all want to watch and see how Neffy performs in the community in people having severe reactions, as well as those with severe rhinitis (not uncommon in allergic patients) before we changed our prescribing significantly.”
Global experts agree that a delay in administering epinephrine among physicians and general public can have catastrophic consequences.
Dr Jones warns about the dangers of delaying adrenaline administration:
“Catastrophe occurs in an allergic reaction when treatment with epinephrine is delayed or not done. Too many will give an antihistamine first and then “wait and see” and this is the wrong thing to do. Much of the reason for this is the needle phobia. I am hopeful that this changes the dynamic and people will be more prone to treat early and treat fast with epinephrine.”
Professor Fox agrees that adrenaline hesitancy is dangerous, adding: “I always felt that the fact it needed an injection made people worry more about using adrenaline and holding back because of possible side effects. Neffy may help with this.”
Furthermore, Dr Jones explains that “Neffy contains sulphites so if someone has a sulphite allergy or sensitivity they should consult with their doctor prior to using. It is currently only approved for those over 30kg. It is a 2mg dose that is equivalent to the 0.3mg dose in a typical Epipen. Hopefully that will change in the future as a 1mg dose is being investigated for those under 30kg.”
Professor Fox says that Neffy is currently awaiting assessment from the relevant authorities in the United Kingdom. “It would then take a few months to assess and from approval to introduction a few months more so hope to see it early to mid-2025.”
On 27 June 2024, the European Medicines Agency recommended the market authorisation approval of its needle-free emergency treatment, EURneffy, for allergic reactions.
Australians are hoping that relevant Australian authorities will evaluate Neffy as a potential local alternative to injectable adrenaline soon.
Photo copyright: ARS Pharmaceuticals
