Individuals with systemic mastocytosis (SM) and a greater risk of severe allergic reactions may soon have more options for carrying and using life-saving epinephrine, including needle-free delivery devices, according to a new review published in Immunology and Allergy Clinics of North America.
Current medical guidelines for anaphylaxis — a severe allergic reaction that can turn fatal without treatment — recommend immediate epinephrine administration. Individuals who are at risk are advised to carry self-injectable devices at all times.
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For decades, epinephrine autoinjectors have been the mainstay of emergency treatment. However, the review notes that these devices face persistent challenges. Fear of needles is a major obstacle, with surveys showing many patients and caregivers would be more likely to carry a needle-free option. Cost, portability and strict storage requirements also limit access and consistent use of autoinjectors worldwide.
Researchers say these barriers have fueled the development of new delivery methods, particularly intranasal sprays and sublingual films (dissolvable strips placed under the tongue) designed to provide similar drug absorption without injections.
One of the most advanced options is an intranasal spray called ARS-1, now marketed as Neffy, which is approved for use in the United States and Europe. Studies comparing the nasal spray with established autoinjectors found that both methods delivered the drug to the bloodstream and affected the body in much the same way. In some situations where more than one dose was needed, the nasal spray even led to higher peak levels of epinephrine than the injectors.
Importantly, research suggests nasal congestion or inflammation, both of which are common during allergic reactions, does not significantly reduce drug absorption.
In an early clinical study of children experiencing allergic reactions during food-challenge testing, 14 out of 15 participants treated with Neffy had complete symptom resolution, with only one requiring additional injected epinephrine.
Other nasal sprays and a sublingual epinephrine film are also in development. Researchers caution that ethical concerns make large randomized trials difficult, so most approvals rely on laboratory and physiological measures rather than traditional clinical trials. Even so, the evidence suggests needle-free epinephrine could reduce hesitation, improve portability and expand global access.
“With these benefits and limitations of novel routes of epinephrine, clinicians and patients/families should use as shared decision-making approach to decide if needle-free epinephrine is the correct choice for them,” the authors concluded.
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