MHRA Approves UK’s First Nasal Spray for Anaphylaxis

An adrenaline nasal spray for the emergency treatment of anaphylaxis has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA).

This marks the first time a needle-free formulation is available in the UK for this use.

The spray, called EURneffy, is manufactured by ALK-Abelló A/S, a pharmaceutical company based in Denmark. It was authorised for use in the European Union in August 2023.

UK approval followed the MHRA’s International Recognition Procedure, introduced in January 2024. The pathway enables the MHRA to align with decisions made by trusted global regulatory partners.

Alternative to Adrenaline Auto-Injectors

Adrenaline is the standard emergency treatment for anaphylaxis and is usually administered by auto-injectors pens. EURneffy is the first approved nasal spray alternative.

The ready-to-use spray is suitable for adults and children weighing 30 kg (about 66 lbs) or more. It delivers its entire contents of 2 mg of adrenaline with a single activation, even when the user has nasal congestion. It is indicated for the emergency treatment of allergic reactions caused by insect stings or bites, foods, medicinal products, and other allergens. It can also be used to treat idiopathic or exercise-induced anaphylaxis. 

According to ALK-Abelló, the product offers a 30-month shelf life and better temperature stability compared with traditional adrenaline auto-injectors. 

Patients Should Always Carry Two Doses

Patients are advised to carry two doses of adrenaline in case a second dose is needed. A second dose should be given in the same nostril after 10 minutes if symptoms persist or recur.

Patients should also inform friends or family about their condition in case help is needed during a reaction.

Biphasic anaphylaxis — a delayed recurrence of symptoms — remains a risk. Patients should seek immediate medical attention after any severe allergic reaction, regardless of whether symptoms resolve.

The MHRA cautioned that the spray’s plunger must not be pressed before insertion into the nostril, as this will release the single dose prematurely.

Efficacy and Tolerability Supported by Trial Data

Presentations at the European Academy of Allergy and Clinical Immunology congress last month in Glasgow highlighted that EURneffy nasal adrenaline spray addressed “unmet needs and current challenges in the emergency management of anaphylaxis.”

Ethical and practical constraints prevent trials in patients experiencing acute anaphylaxis. However, data from ALK-Abelló’s development programme, involving more than 700 participants, demonstrated that the spray produced a pharmacological response comparable with that of intramuscular adrenaline auto-injectors.

Real-world data also supported the effectiveness of the nasal adrenaline spray in acute situations.

No serious adverse events were reported in clinical studies. The most frequently occurring adverse reactions were reported only after a second 2 mg dose (4 mg total). These included throat irritation (18.8%), headache (17.6%), nasal discomfort (12.9%), and feeling jittery (10.6%).

Ongoing Safety Monitoring

The MHRA will continue to monitor the safety and effectiveness of EURneffy.

Healthcare professionals and patients are urged to report suspected side effects through the Yellow Card scheme.

Further information, including the Patient Information Leaflet and Summary of Product Characteristics, will be available on the MHRA website within seven days of approval.

Dr Sheena Meredith is an established medical writer, editor, and consultant in healthcare communications, with extensive experience writing for medical professionals and the general public. She is qualified in medicine and in law and medical ethics.