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Italy approves adrenaline nasal spray for anaphylaxis treatment
An adrenaline nasal spray has been approved for use in Italy as a life-saving alternative to traditional intramuscular injections for treating anaphylaxis. The device received authorization from the Italian Medicines Agency (AIFA), following prior approvals from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
Medical experts from the Italian Society of Allergology, Asthma, and Clinical Immunology (SIAAIC) noted that the spray addresses common barriers to emergency treatment, such as needle phobia and the social stigma of self-injection, which often lead to delays in care. Currently, the spray is indicated for individuals weighing over 30 kilograms. A pediatric formulation is expected to become available in the spring.
In Italy, approximately 10,000 cases of anaphylaxis are recorded annually, resulting in 60 deaths. Specialists highlighted that the nasal spray offers a longer shelf life of 30 months compared to the 18 months typical of standard auto-injectors, potentially improving accessibility and emergency preparedness.
Entities
European Medicines Agency · Food and Drug Administration · Italian Medicines Agency · Italy · SIAAIC
Claims
What the coverage asserts, and how many sources carry each claim.
- [○ 1 SOURCE] The nasal spray has a shelf life of 30 months. www.notiziedabruzzo.it
- [● 5 SOURCES] A pediatric spray formulation is expected to arrive in Italy in the spring. www.codirp.it · www.corcianonline.it · www.notiziedabruzzo.it · lamilano.it · www.lsdmagazine.com
- [● 4 SOURCES] The device was previously approved by the FDA and EMA. www.codirp.it · www.corcianonline.it · lamilano.it · www.lsdmagazine.com
- [○ 1 SOURCE] Between 25% and 60% of patients tend to refuse or delay injection. www.notiziedabruzzo.it
- [● 5 SOURCES] The spray is currently indicated for individuals weighing at least 30 kilograms. www.codirp.it · www.corcianonline.it · www.notiziedabruzzo.it · lamilano.it · www.lsdmagazine.com
- [● 5 SOURCES] The nasal spray was approved by the Italian Medicines Agency (AIFA). www.codirp.it · www.corcianonline.it · www.notiziedabruzzo.it · lamilano.it · www.lsdmagazine.com
- [● 5 SOURCES] An adrenaline nasal spray is now available in Italy for treating anaphylaxis. www.codirp.it · www.corcianonline.it · www.notiziedabruzzo.it · lamilano.it · www.lsdmagazine.com
- [● 5 SOURCES] Italy records approximately 10,000 anaphylaxis cases and 60 deaths annually. www.codirp.it · www.corcianonline.it · www.notiziedabruzzo.it · lamilano.it · www.lsdmagazine.com