The UK has approved its first-ever needle-free adrenaline treatment for severe allergic reactions, marking a major development in how anaphylaxis could be managed in emergencies
The Medicines and Healthcare products Regulatory Agency (MHRA) has officially approved EURneffy, the first-ever needle-free adrenaline nasal spray in the UK, specifically designed for the emergency treatment of anaphylaxis in both adults and children weighing over 30 kg. This landmark approval signifies a pivotal advancement in addressing severe allergic reactions, offering patients a potentially life-saving alternative to traditional injection methods that have long been the standard.
Understanding anaphylaxis and its impact
Anaphylaxis is characterised by its sudden onset and severity, representing a critical and potentially fatal allergic reaction. It may lead to a rapid drop in blood pressure, swelling of the throat, and severe respiratory difficulties, necessitating immediate intervention. Statistics show that in Europe, approximately eight out of every 100,000 individuals are affected by anaphylaxis annually, with one in 300 people experiencing such a reaction at some point in their lives. The standard emergency treatment for anaphylaxis involves the administration of adrenaline, typically delivered through auto-injectors, which can pose challenges for some patients in emergency scenarios.
A new era in emergency treatment
The MHRA’s approval of EURneffy introduces a pioneering nasal spray formulation that facilitates the immediate availability of this essential medication in emergencies. One of the notable advantages of EURneffy over existing adrenaline auto-injectors is its extended shelf life and enhanced stability at a range of temperatures, addressing common concerns regarding the storage and longevity of adrenaline products.
Julian Beach, the Interim Executive Director of Healthcare Quality and Access at the MHRA, emphasised the agency’s commitment to patient safety, stating, “Patient safety is our top priority, which is why we’re pleased to see the first needle-free nasal spray formulation of adrenaline for the emergency treatment of anaphylaxis. Until now, patients have only had access to auto-injectors for self-administration of adrenaline.
“While this represents an important new option, it is crucial to note that adrenaline auto-injectors remain a vital and potentially life-saving treatment, providing individuals experiencing anaphylaxis with precious time before professional medical help arrives. We strongly encourage everyone at risk of severe allergic reactions, as well as those in their vicinity, to educate themselves on emergency response protocols. The MHRA website offers valuable resources and guidance to help individuals prepare for such situations.”
User-friendly adrenaline for allergy patients
The approval of EURneffy follows an extensive review of clinical data from the product’s development program, which involved 700 participants. This rigorous evaluation revealed no adverse events associated with the nasal spray. It provided comprehensive clinical pharmacological data indicating that the 2 mg dosage of EURneffy demonstrates pharmacodynamics and pharmacokinetics comparable to those of traditional auto-injectors, analysed across a variety of dosing conditions.
The MHRA has issued specific recommendations for users to maximise the efficacy of the nasal spray. It’s essential not to press the nozzle before inserting it into the nostril, as this can result in the loss of the single dose before it’s used. Furthermore, patients are advised always to carry two nasal sprays to ensure that a second dose can be administered if necessary. Additionally, it is recommended to inform friends, family, or colleagues about the presence of the sprays in case of an emergency.
Henriette Mersebach, MD, the Executive Vice President of Research and Development at ALK, expressed her enthusiasm about the new treatment option, stating, “The approval of EURneffy® 2 mg in the UK marks a significant milestone in offering a novel adrenaline treatment for adult and adolescent patients facing life-threatening allergies. The introduction of EURneffy® has the potential to greatly enhance the quality of life for those suffering from severe allergic reactions. It serves as an important encouragement for patients and caregivers to carry adrenaline with them at all times.”
This development not only opens doors for more accessible treatment options but also reinforces the importance of preparedness in managing severe allergic reactions.
