US FDA approves nasal spray alternative to EpiPen for allergic reactions

[August 12, 2024]  By Sriparna Roy and Christy Santhosh

(Reuters) -The U.S. Food and Drug Administration has approved ARS Pharmaceuticals' nasal spray as the first needle-free emergency treatment for potentially fatal allergic reactions.

The spray, which will be sold under the brand name neffy, is seen as an alternative to EpiPen and other autoinjectors that are filled with epinephrine, a life-saving drug used by people at risk of anaphylaxis and other allergic reactions.

Neffy is expected to be available in the United States within eight weeks of FDA approval, the company said.

ARS Pharma will offer neffy at a price of $199 for two doses via digital pharmacy sites like BlinkRx and GoodRx for eligible patients whose insurance plans do not cover neffy. Some commercially insured patients can access the treatment at $25 for each filled prescription of two single-use neffy devices through a co-pay savings program.

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, is approved for use in adult and pediatric patients who weigh at least 30 kilograms.

"Some people, particularly children, may delay or avoid treatment due to fear of injections," said Kelly Stone, an associate director at the FDA's Center for Drug Evaluation and Research, adding that the availability of the nasal spray may reduce barriers to rapid treatment.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

Last year, the U.S. health regulator declined to approve the spray and requested additional testing, in a decision that went against the recommendation from its independent experts.

Lianne Mandelbaum, a parent of a child with food allergies that Reuters contacted through ARS Pharma, said the decision was long awaited and has the "potential to be a game changer for the community."

"I don't see doing a complete switch over yet," she said, adding that she would continue carrying the auto injectors as well as neffy.

Shares of ARS rose over 13% to $11.22 on the FDA approval.

(Reporting by Sriparna Roy and Christy Santhosh in Bengaluru; Editing by Devika Syamnath and Shailesh Kuber)

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