Newly approved needle-free adrenaline spray offers longer shelf life, better stability, and easier use, signaling a shift in emergency drug delivery design.
Young man having asthma attack or choking suffering from respiration problems | Image Credit: © Feodora - stock.adobe.com
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved EURneffy 2 mg, a needle-free adrenaline nasal spray designed to treat anaphylaxis in adults and children weighing 30 kilograms (66 pounds) or more in the United Kingdom (1). It’s the first product of its kind authorized in the country, and its launch is anticipated in the latter half of 2025, following final market access negotiations.
This milestone approval introduces a fundamentally different route of administration for emergency adrenaline, delivered intranasally rather than via auto-injector (1). The shift comes as manufacturers and developers across the pharmaceutical industry continue to explore more intuitive, less invasive drug delivery formats that can meet real-world demands, particularly in high-stakes use cases like allergic reactions (2–6).
·MHRA approval of EURneffy introduces the first nasal adrenaline spray for anaphylaxis, offering a needle-free alternative to traditional auto-injectors.
·EURneffy features 30-month shelf life and high temperature stability, addressing long-standing cold chain and storage challenges in pharma logistics.
·The product’s design reflects growing industry emphasis on human factors engineering to improve real-world usability and adherence in emergency drug delivery.
EURneffy’s design eliminates the needle entirely, a departure from decades of reliance on injection-based delivery (1). For patients and caregivers, this simplifies use during the chaotic moments of anaphylaxis, when speed and confidence are critical. It also opens new considerations for drug-device development: designing for intuitive usability while maintaining pharmacologic equivalence to injectable formats.
Henriette Mersebach, MD, executive vice president of research and development at ALK, emphasized this point in a statement, stating, “The approval of EURneffy 2 mg in the UK introduces an alternative and novel adrenaline treatment option for adult and adolescent patients with life-threatening allergies. EURneffy could improve the lives of people with severe allergic reactions and may facilitate that patients and caregivers continually carry adrenaline wherever they go" (1).
The product is also formulated to be stable for up to 30 months and at a wider range of temperatures than existing auto-injectors (1). This extended stability means fewer constraints in transportation and storage, allowing for broader reach and potentially reducing waste from expired inventory. It also reflects a growing focus within pharma on formulations that ease cold-chain requirements without compromising efficacy (7–11).
MHRA approval followed a review of data from more than 700 participants enrolled in the EURneffy development program (1). Across a range of dosing scenarios, the pharmacokinetic and pharmacodynamic profiles of the nasal spray were consistent with those of traditional auto-injectors. No serious adverse events were reported during clinical studies.
Anaphylaxis affects approximately eight in every 100,000 people annually in Europe, and about one in 300 will experience it at some point in their lives (1). Despite this prevalence, hesitancy and misuse around auto-injectors remain common. EURneffy highlights how thoughtful design and delivery innovation can help improve adherence by minimizing user burden.
The nasal spray was originally developed by ARS Pharmaceuticals, based in the United States (1). In 2024, ALK entered into a licensing agreement with ARS to commercialize the product outside the United States, Australia, New Zealand, Japan, and China. The partnership expanded in 2025 to include co-promotion in the US market.
Although the approval marks a significant product development and regulatory milestone, the company noted it will not impact its financial guidance for 2025 (1).
References
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