FDA approves first nasal spray for anaphylaxis
FDA approves first nasal spray for anaphylaxis
Today the FDA announced the approval of the first epinephrine nasal spray to treat allergic reactions that are considered an emergency and life-threatening (anaphylaxis). The agency granted the approval of neffy, which is for adult and pediatric patients weighing at least 66 pounds, to ARS Pharmaceuticals.
“Today’s approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection. Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections,” said Kelly Stone, M.D., Ph.D., associate director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research, in an agency news release. “The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis. As a result, neffy provides an important treatment option and addresses an unmet need.”
Neffy is administered via a single spray into one nostril. “As with epinephrine injection products, a second dose (using a new nasal spray to administer neffy in the same nostril) may be given if there is no improvement in symptoms or symptoms worsen,” the FDA notes. “Patients may need to seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event further treatment is required.”
Reuters
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