Latest news with #EURneffy
Medscape
18-07-2025
- Health
- Medscape
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.
Telegraph
18-07-2025
- Health
- Telegraph
First nasal spray for allergic reactions now available in UK
The first needle-free emergency treatment for anaphylaxis – in the form of a nasal spray – will now be available in the UK. The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the adrenaline (epinephrine) nasal spray (EURneffy) for emergency treatment. The manufacturer, ARS Pharma, has been contacted for comment about whether it plans to seek wider approval for use on the NHS. Julian Beach, MHRA interim executive director of healthcare quality and access, said: '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. 'We continue to encourage everyone at risk of severe allergic reactions, and those around them, to familiarise themselves with how to respond in an emergency. 'Resources and guidance are available on the MHRA website to help people be prepared.' Anaphylaxis is a sudden and life-threatening allergic reaction that can cause a drop in blood pressure and breathing difficulties. EURneffy is intended for use in adults and children who weigh 30kg (about 66lb) or more, and can be used even if people have colds or blocked noses. It is a single dose nasal spray that delivers its entire contents (2mg) upon activation. People are reminded that the plunger should not be pressed before inserting the product into the nostril, otherwise the single dose will be lost. The MHRA said patients should always carry two nasal sprays with them in case a second dose is needed, and tell family and friends where it is.
