Italy Introduces First Needle-Free Epinephrine Nasal Spray for Severe Allergic Reactions
Italy has added its first epinephrine nasal spray to the market as an alternative treatment for severe allergic reactions and anaphylaxis, according to an announcement by specialists at the Italian Society of Allergology, Asthma and Clinical Immunology (Siaaic) during their 38th national congress in Salerno, Il Mattino reported.
The needle-free device matches the efficacy of traditional intramuscular auto-injectors while offering a longer shelf life and easier storage. Anaphylaxis affects approximately 10,000 people annually in Italy and causes about 60 deaths each year, driven largely by triggers such as foods, insect stings, and medications, according to Mario Di Gioacchino, former president of Siaaic.
While intramuscular adrenaline remains the standard first-line treatment for anaphylaxis, clinical data show that 25% to 60% of patients refuse to inject the medication, and those who do often experience treatment delays of up to nine minutes, as noted by Siaaic president Vincenzo Patella. The nasal spray aims to bridge that gap by removing the psychological barrier of needles, particularly for young patients.
Availability and Regulatory Approvals for the New Device
The Italian Medicines Agency (AIFA) greenlit the nasal spray following previous approvals from the U.S. Food and Drug Administration and the European Medicines Agency in August 2024.
Current prescribing guidelines limit the device to individuals weighing more than 30 kilograms, requiring physicians to evaluate appropriate candidates during daily clinical practice. A pediatric version of the nasal spray, which received AIFA approval in July, is expected to launch in the spring.
Allergies represent the most widespread chronic condition in Europe, affecting an estimated 150 million people, with roughly 20% of those experiencing severe allergies living with the daily fear of an uncontrollable anaphylactic shock, according to Patella (Il Mattino).
Frequently Asked Questions About the Adrenaline Nasal Spray
Which regulatory bodies approved the epinephrine nasal spray in Italy?
The Italian Medicines Agency (AIFA) granted the final green light for the market launch, following prior approvals from both the U.S. Food and Drug Administration and the European Medicines Agency.
Who is currently eligible to receive the new nasal spray?
The device is available only for patients weighing more than 30 kilograms, with doctors assessing suitability on a case-by-case basis during routine clinical practice (Il Mattino).
When will pediatric patients gain access to the treatment?
A specialized pediatric version of the nasal spray received approval from AIFA in July and is scheduled to arrive on the market in the spring.
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