EpiPen Alternative for Anaphylaxis Approved by FDA — No Needles

Mar. 15, 2025

ARS Pharmaceuticals, Inc.

“Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections,” Kelly Stone, MD, PhD, Associate Director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research, said in a statement.

Stock image of the EpiPen auto-injector.Daniel Acker/Getty Images

“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.”

As theMayo Clinicexplains, “Anaphylaxis is a severe, life-threatening allergic reaction. It can happen seconds or minutes after you’ve been exposed to something you’re allergic to. Peanuts or bee stings are examples.”

Anaphylaxis “occurs in about one in 50 Americans,” theAsthma and Allergy Foundation of Americastates, adding, “Many believe the rate is higher than that. It is probably closer to one in 20.”

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The Mayo Clinic says symptoms include skin reactions (like hives), low blood pressure, nausea, fainting — and “constriction of the airways and a swollen tongue or throat, which can cause wheezing and trouble breathing.”

Food allergies are on the rise, according toFood Allergy Research and Education, with 33 million Americans citing at least one food allergy.

“Milk, egg, peanut, tree nuts, wheat, soy, fish and crustacean shellfish were identified as responsible for at least 90 percent of the serious food allergy reactions in the U.S.,” the organization says.

Peanuts are the most common-cause of a food-related allergic reaction.Getty

Getty

Peanut allergies, specifically, are rising — and as theMayo Clinicpoints out, “Peanut allergyis the most common cause of food-induced anaphylaxis.”

“Even tiny amounts of peanuts can cause a serious reaction that can even be life-threatening.”

In January, a25-year-old with a nut allergy diedof anaphylactic shock after eating cookies that didn’t list peanuts on the label, and last year,a man from Texas diedafter eating a taco that didn’t list peanut butter as an ingredient.

Although no details have been released about when Neffy will be available, the FDA has granted the productFast Trackstatus, which expedites its release to the public.

source: people.com