“Neffy” offers a needle-free option for rapid emergency treatment of severe allergic reactions.
The U.S. Food and Drug Administration (FDA) has approved Nephi, the first epinephrine nasal spray for emergency treatment of severe allergic reactions, including life-threatening anaphylaxis, in adults and children. Nephi is administered once into each nostril, although a second dose may be needed if symptoms persist or worsen.
“Anaphylaxis can be life-threatening, and people, especially children, may delay or avoid treatment due to fear of injections,” said Kelly Stone, M.D., deputy director of the division of pulmonary, allergy and critical care in the FDA’s Center for Drug Evaluation and Research. “The availability of epinephrine nasal spray may reduce a barrier to prompt treatment of anaphylaxis. As a result, Nephi provides an important treatment option and addresses an unmet need.”
Anaphylaxis is a severe condition triggered by allergens such as certain foods, medicines or insect bites, and epinephrine, usually administered by injection, is the only life-saving treatment. Neffy was approved with Fast Track designation by the FDA for ARS Pharmaceuticals.
Follow the Lord’s guidance and join us in praying…
- Stone, deputy director of the FDA’s Division of Respiratory Medicine, Allergy and Critical Care Medicine, promotes testing of treatments and medicines.
- Chairman Robert Califf and FDA staff to review treatments and evaluate recommendations and research for drug approval.
- Those at risk of anaphylactic shock would benefit from an intranasal therapeutic release.
source: Food and Drug Administration
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