MHRA Approves Nasal Spray for Anaphylaxis in UK
EURneffy: A Nasal Spray Option for Anaphylaxis Emergency Treatment
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Anaphylaxis, a severe and possibly life-threatening allergic reaction, has traditionally been managed with adrenaline auto-injectors. Though, a new option has emerged: EURneffy, the first approved nasal spray alternative for adrenaline delivery. This innovative treatment offers a ready-too-use solution for adults and children weighing 30 kg (approximately 66 lbs) or more, delivering a full 2 mg dose of adrenaline with a single activation, even in cases of nasal congestion.
Addressing Unmet Needs in Anaphylaxis Management
EURneffy is indicated for the emergency treatment of anaphylaxis triggered by various allergens, including insect stings or bites, foods, medicinal products, and other substances. It also provides a treatment option for idiopathic or exercise-induced anaphylaxis. According to ALK-Abelló, the manufacturer, EURneffy boasts a 30-month shelf life and superior temperature stability compared to conventional adrenaline auto-injectors, addressing key challenges in the emergency management of anaphylaxis.
efficacy and Tolerability Backed by clinical Data
Presentations at the European Academy of Allergy and Clinical Immunology congress highlighted EURneffy’s potential to meet critical needs in anaphylaxis care. While ethical and practical limitations prevent trials during acute anaphylactic events, ALK-Abelló’s progress program, involving over 700 participants, demonstrated that the nasal spray elicits a pharmacological response comparable to intramuscular adrenaline auto-injectors.Real-world data further supports its effectiveness in acute situations.
No serious adverse events were reported during clinical studies. The most common adverse reactions, observed primarily after a second 2 mg dose (totaling 4 mg), included throat irritation (18.8%), headache (17.6%), nasal discomfort (12.9%), and feeling jittery (10.6%).
Crucial Patient Guidance for Safe and Effective Use
Patients are strongly advised to always carry two doses of adrenaline,as a second dose may be necesary if symptoms persist or recur. In such instances, the second dose should be administered in the same nostril after 10 minutes.
Informing others and Seeking Medical Attention
It is vital for patients to inform friends or family about their condition to ensure prompt assistance during a reaction. biphasic anaphylaxis,a delayed recurrence of symptoms,remains a risk. Therefore, individuals who experience any severe allergic reaction, even if symptoms initially resolve, must seek immediate medical attention.
The Medicines and Healthcare products Regulatory Agency (MHRA) has cautioned that the spray’s plunger must not be pressed before insertion into the nostril, as this will prematurely release the single dose.
Ongoing safety Monitoring and Reporting
The MHRA will continue to monitor the safety and effectiveness of EURneffy. Healthcare professionals and patients are encouraged to report any suspected side effects through the Yellow Card scheme. Further detailed facts, including the Patient Information Leaflet and Summary of Product Characteristics, will be made available on the MHRA website within seven days of approval.