Allergies

Anaphylactic shock: an adrenaline nasal spray is on the way, due to be available for children this spring

The medicine approved by AIFA complements auto-injectors: needle-free and just as effective, it is a life-saving treatment that enables prompt intervention

 zakalinka - stock.adobe.com

4' min read

Translated by AI
Versione italiana

4' min read

Translated by AI
Versione italiana

Anaphylactic shock is a severe, systemic and potentially fatal allergic reaction that develops rapidly, often within a few minutes of exposure to the allergen. Triggered by wasp and bee stings, medicines, or foods such as nuts, its symptoms include breathing difficulties and a drop in blood pressure. During an anaphylactic reaction, large quantities of histamine and other substances are released into the body, causing a sudden and rapid dilation of the blood vessels, which may lead to a drop in blood pressure and possible loss of consciousness. In such cases, immediate intervention is required, involving the immediate administration of adrenaline.

How adrenaline works

“The standard treatment for an anaphylactic reaction,” explains Mario Di Gioacchino, Past President of the Italian Society of Allergology, Asthma and Clinical Immunology (SIAAIC) – Senior Consultant at Synergo – Institute of Clinical Immunotherapy and Advanced Biological Treatments in Pescara – is the prompt administration of epinephrine (adrenaline). This drug is essential for counteracting the rapid drop in blood pressure and symptoms affecting the airways (including bronchospasm), and it works by binding to a specific type of receptor, known as adrenergic receptors, thereby reducing the vasodilation and increased permeability of blood vessels caused by histamine released during the response to an allergen. This is why prompt treatment leads to improved blood flow and easier breathing.”

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Until now, adrenaline for anaphylactic shock could only be administered via an auto-injector, usually into the thigh, even over clothing. From today, however, a nasal spray version is also available for adults, and from next spring it will also be available for children. The announcement comes during the 38th national congress of the Italian Society of Allergology, Asthma and Clinical Immunology (Siaaic), currently taking place in Salerno: approved in August 2024 by the Food and Drug Administration and the European Medicines Agency, the nasal spray has also been given the green light by AIFA.

“Allergies are the most common chronic condition in Europe, with estimates suggesting that around 150 million Europeans are affected by some form of allergy,” says Vincenzo Patella, president of Siaaic and Head of the Internal Medicine Unit at the Salerno Health Authority. “Among these, around 20 per cent of people suffering from severe allergic conditions live every day in fear of anaphylactic shock or of dying as a result of an uncontrolled reaction. In Italia, there are 10,000 cases recorded each year, with 60 fatalities.”

Issues with the auto-injector

Over time, critical issues have emerged regarding the use of the auto-injector, particularly in relation to the difficulties experienced by patients and carers. “Although intramuscular adrenaline is recognised as the first-line treatment for anaphylaxis,” emphasises Patella – clinical reality shows that between 25% and 60% of patients refuse to inject themselves with the drug and that, in cases where they do, administration is delayed”. According to the SIAAIC president, the data show that patients or their carers wait up to nine minutes before administering the injection – a delay that can prove critical in an emergency situation where speed is a determining factor in the clinical outcome. “The aim of the spray is to reverse this trend, given that only 7 per cent of adults and 21 per cent of children receive adrenaline in time,” emphasises Patella.

There are many reasons for this delay. Psychological barriers are often one of the main obstacles. The fear of needles and the anxiety associated with having to administer an injection in a moment of panic act as a significant deterrent; added to these, particularly amongst younger people, is the embarrassment of having to inject oneself in front of others, and often a lack of confidence about how to use the device correctly, despite patients being told what to do in an emergency. As a result, between 20 per cent and 70 per cent of people with allergies administer their life-saving medication incorrectly. Finally, some studies have shown that as many as between 24 per cent and 50 per cent of patients do not purchase the injector or, once it has expired, do not replace it. Meanwhile, 50 per cent of people do not always carry adrenaline with them.

The search for alternative options

It is precisely these limitations that have led to the search for alternative ways of administering the drug. The nasal spray – small, needle-free and easy to use – was developed as a practical solution to these barriers, which still today hinder the optimal management of anaphylaxis.

“Based on the clinical results obtained, the intranasal route of administration is a valid and effective alternative for the emergency administration of adrenaline,” Patella points out. To begin with, the shelf life is 30 months, with no need for special storage conditions, unlike that of the auto-injector, which must be replaced 18 months after manufacture. This shelf life is often reduced to just one year from the date of purchase, as it generally takes the supply chain six months to get the auto-injector onto pharmacy shelves.”

Despite the amount of positive scientific evidence, it will be necessary to assess in practice for which patients it is more or less appropriate to recommend this method of administration.

“At present, the spray is only available to people weighing at least 30 kilograms, effectively excluding younger children or infants, for whom specific auto-injectors are available,” concludes Patella. “The good news is that the paediatric formulation, which was already approved by AIFA in July, will arrive in our country next spring. Furthermore, given the characteristics of the medicine, its safety profile in specific patient groups, such as those with heart conditions and the elderly, will need to be assessed in everyday clinical practice,”

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