The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for EURneffy, an adrenaline (epinephrine) nasal spray for treating anaphylaxis.

Developed by US biotech ARS Pharmaceuticals and under exclusive license in the UK by Danish pharmaceutical company ALK-Abelló, the single-dose nasal spray is indicated for use in adults and children weighing over 30kg and delivers its entire contents (2mg) upon activation.

Anaphylaxis is an allergic reaction characterised by breathing difficulties and a drop in blood pressure. The reaction can be life-threatening in some individuals.

MHRA interim executive director of healthcare quality and access Julian Beach commented: “Patient safety is our top priority, which is why we’re pleased to approve the first needle-free nasal spray formulation of adrenaline for the emergency treatment of anaphylaxis in the UK. Until now, adrenaline for self-administration has only been available via auto-injectors.

“While this represents an important new option, adrenaline auto-injectors remain a vital and potentially life-saving treatment, giving people experiencing anaphylaxis valuable time before emergency help arrives.”

ALK signed an agreement with ARS for the exclusive licensing and commercialisation rights to EURneffy in the UK and EU last year. The spray’s UK approval follows its launch in Spain in 2024 and in Germany last month.

ALK also holds the rights for EURneffy in Canada while ARS has established licensing partnerships for the spray in China, Japan, and Australia and New Zealand with Pediatrix Therapeutics, Alfresa Pharma, and CSL Seqirus, respectively.

In May, ALK entered a four-year co-promotion agreement with ARS for its nasal spray in the US – in which the spray is marketed as neffy – to co-promote it to up to 9,000 paediatricians. Under the agreement, ALK will be eligible for a performance-related revenue share provided that net sales exceed certain market share thresholds from the targeted paediatrician prescribers, as per a news release from the company.

Several innovative epinephrine delivery methods are in development for anaphylaxis as alternatives to injections. These include Anaphylm, a fast-dissolving sublingual strip developed by US company Aquestive Therapeutics.