The Food and Drug Administration has approved ARS Pharmaceuticals’ nasal spray as the first needle-free emergency treatment for potentially fatal allergic reactions, the agency said on Friday. Anaphylaxis is a severe, life-threatening allergic reaction that typically involves multiple parts of the body and is considered a medical emergency. Neffy, a single-dose nasal spray administered into one nostril, was approved for use in adult and pediatric patients who weigh at least 66 pounds. Neffy’s approval is based on four studies in 175 healthy adults without anaphylaxis that measured the epinephrine concentrations in the blood following administration of Neffy or approved epinephrine injection products. Last year, the FDA declined to approve the spray and requested additional testing, in a decision that went against the recommendation from its independent experts.

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Persons: ”, Kelly Stone Organizations: Drug Administration, FDA’s Center, Drug