Needle-free nasal adrenaline treatment under review for approval in Canada and the UK

ARS Pharmaceuticals has made significant progress in expanding access to neffy®, its needle-free adrenaline (epinephrine) nasal spray. After gaining approval in the U.S. and Europe for treating severe allergic reactions like anaphylaxis, ARS Pharmaceuticals has now filed for approval in Canada and the UK, where it will be called EURneffy®. This development brings neffy® closer to becoming an accessible option for managing severe allergic reactions in more countries around the world. 

In November 2024, ARS pharma announced a licensing agreement providing ALK (a global company that provides a variety of allergy treatments and services to help allergy sufferers, their families, and healthcare professionals) with exclusive rights to commercialise neffy® in Europe, Canada, United Kingdom, and certain other places outside the United States.

What is neffy®? 

neffy® is the first needle-free, intranasal adrenaline product to receive regulatory approval for treating severe allergic reactions (anaphylaxis). It received approval in both the United States and Europe in 2024. 

Although previous research and experimental nasal adrenaline products have been developed, neffy® is the first to gain official approval for this use. Traditionally, adrenaline for anaphylaxis has only been available via auto-injectors — portable pre-loaded devices that deliver adrenaline through a needle into the thigh muscle during an emergency.  

The neffy® 2 mg nasal spray is intended for emergency use in both adults and children who weigh 66 pounds (30 kg) or more, offering an alternative, needle-free delivery method for those at risk of severe allergic reactions. This innovative option could help quickly address severe allergic emergencies, potentially saving lives without the need for injections. 

Why is this development important? 

Anaphylaxis, can occur within minutes of exposure to allergens, making rapid treatment essential to managing symptoms. However, research shows that some people delay using auto-injectors due to fear or uncertainty about using needles. 

neffy® provides a needle-free alternative through a nasal spray, which may help overcome this barrier and encourage more timely administration of adrenaline in emergency situations.  

The approval process 

neffy® has not yet been approved in the UK or Canada and still needs to navigate important regulatory steps before becoming available. However, ARS Pharmaceuticals’ filings in both Canada and the UK bring neffy® closer to becoming available to patients in these regions. The applications are currently under review by Health Canada and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). 

The approval process may take some time, as regulators carefully examine the clinical data supporting neffy®, however, allergy experts in the UK expect that neffy® could be approved by the summer time. Once approved, healthcare professionals may begin considering these devices for appropriate patients. Availability will depend on manufacturing supply and the preferences of the prescribing doctor.  

What’s next? 

ARS Pharma is also testing neffy® to treat sudden flare-ups in patients with chronic urticaria (hives). They plan to start a mid-stage clinical trial (Phase 2b) in early 2025. Additionally, their agreement with ALK gives them exclusive rights to use this treatment for any new medical uses in the regions covered by the deal. 

This treatment could mark a turning point in allergy management, offering an alternative option to traditional allergy medication. Success with neffy® could also inspire further advancements in non-invasive treatments for other allergic conditions, broadening the horizon for allergy care in the future. 

For the full report, visit: https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-files-approval-neffyr-canada-and-united