The Food and Drug Administration has approved ARS Pharmaceuticals’ nasal spray as the first needle-free emergency treatment. Can cause fatal allergic reactionsThe department made the announcement on Friday.
The spray, sold under the brand name Nephi, is seen as an alternative to other auto-injectors such as EpiPen and Caleo’s Orbi-Q, which are filled with epinephrine, a life-saving drug used by people at risk of anaphylaxis and other allergic reactions.
Anaphylaxis is a severe, life-threatening allergic reaction that usually affects multiple parts of the body and is considered a medical emergency.
Nefi is a nasal spray administered once into one nostril and is approved for use in adults and pediatric patients weighing 66 pounds or more.
“Some people may delay or avoid treatment because they’re afraid of injections,” said Kelly Stone, deputy director of the FDA’s Center for Drug Evaluation and Research, adding that the availability of a nasal spray could reduce a barrier to speedy treatment.
Neffy’s approval is based on four studies that measured blood epinephrine levels in 175 healthy adults without anaphylaxis after administration of Neffy or an approved epinephrine injection.
The FDA refused to approve the spray last year and called for additional testing, a decision that went against the recommendations of independent experts.
