How a needle-free treatment option for anaphylaxis could change the landscape of emergency allergy management 

An exciting development is on the horizon for the treatment of anaphylaxis – a needle-free device called ‘neffy’ which is pending approval in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA).    

Neffy was approved in August 2024 in Europe and in the US as a prescription-only medication by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) for the emergency treatment of anaphylaxis.    

The World Allergy Organisation (WAO) defines anaphylaxis as “a serious systemic hypersensitivity reaction that is usually rapid in onset and may cause death. Anaphylaxis is a serious and potentially life-threatening medical emergency that requires the prompt administration of adrenaline.”  

Currently, the only available treatment for people living with severe expressions of allergy that carry the risk of anaphylaxis is an injectable form delivered by an adrenaline auto injector device (AAI) delivering an intramuscular dose of adrenaline into the thigh muscle.     

Neffy, by contrast, is a non-invasive and needle-free. It is a unit dose spray device containing “adrenaline” – also known as Epinephrine – and is designed to be administered into one nostril (intranasally). As with injectable adrenaline devices, a second dose may be given. For neffy, this would be into the same nostril if there is no improvement in symptoms or if symptoms worsen.    

This type of device has been used for many years to administer other types of medication intranasally, so the device itself is not a new concept (1).  However, a needle-free option will appeal to  people who are reluctant to use adrenaline auto injector devices based on factors including needle phobia, being unsure of how it may feel, what it looks like and hesitancy over whether they have made the correct judgement call on the severity of symptoms. Research studies have highlighted a delay in administering adrenaline as a risk factor for poor outcomes and even fatal outcomes (2).  

Some additional potential advantages of neffy, include:        

•   Longer expiry dates. Neffy devices typically have a 30-month lifespan which means they are unlikely to need replacing as frequently as AAI’s which lose time significantly as they move along the supply chain from manufacturer to customer. The impact of a longer shelf life will be beneficial to people prescribed this treatment and may prove to be more cost-effective to the NHS. 
• User-friendly. Neffy devices are lightweight and needle-free; they are small enough to be stored and carried in a pocket or within close reach, for example, in a bag. This is particularly advantageous for older children and young people who may have been reluctant to carry auto injector devices due to their size. This is a concern for HCP’s and parents alike as it increases the risk of a delay in potentially lifesaving treatment.

Like all treatments and medications, there are some potential limitations to consider. At present, neffy is only available to treat children and adults who weigh over 30kg, excluding a significant proportion of children for whom the needle-free option would be appealing.  

Also, neffy has some side-effects from administering via the intranasal route which include:      

• Throat irritation
• Nasal tingling, discomfort and congestion 
• Nasal itch, sneezing, runny nose 
• Headache 
• Fatigue  
• Tremors /Jitteriness  
• Gum pain /Oral numbness
• Abdominal pain, nausea and vomiting 

Summary  

If this treatment option becomes available for use in the UK, it has the potential to be a game changer for people managing severe allergies. However, the downside of a relatively new treatment is a lack of field data around effective use.   

While we await the decision from the MHRA on whether this product is deemed safe and effective, those working in the specialty of allergy will no doubt be observing the roll-out of neffy in the United States to better understand this treatment and its effectiveness.   

 Reference List:    

1.Development of neffy, an Epinephrine Nasal Spray, for Severe Allergic Reactions. Anne Ellis et al Journal of Pharmaceutics 2024 Jun 14;16(6):811. doi: 10.3390/pharmaceutics16060811    Web address:  https://pmc.ncbi.nlm.nih.gov/articles/PMC11207568/#:~:text=Across%20a%20range%20of%20studies,after%20treatment%2C%20which%20confirms%20activation  

2.Evidence update for the treatment of anaphylaxis Dodd et al Journal of Resuscitation  2021 Jun;163:86–96. doi: 10.1016/j.resuscitation.2021.04.010  Web address: https://pmc.ncbi.nlm.nih.gov/articles/PMC8139870/#:~:text=There%20is%20little%20doubt%20that,reactions%2C%20hypotension%20and%20fatal%20outcomes.