EpiPen Alternative for Anaphylaxis Approved by FDA — No Needles
The nasal spray Neffy is the first non-injectable epinephrine to treat the life-threatening allergic response
ARS Pharmaceuticals, Inc.
Neffy, a nasal spray alternative to the EpiPen and similar injectables, has been approved by the FDA.The first-ever needle-free alternative to the EpiPen and similar epinephrine autoinjectors has been approved by the Food and Drug Administration to treat anaphylaxis.
Neffy, a nasal spray that delivers a dose of epinephrine, is the first of its kind that isn’t delivered by injection. Until Neffy’s approval, the only way to stop the life-threatening response to an allergic reaction was with an injectable like the EpiPen, which comes pre-filled with a dose of the medication.
“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.
“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 the Mayo Clinic explains, “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,” the Asthma and Allergy Foundation of America states, 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 to Food 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.
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Peanuts are the most common-cause of a food-related allergic reaction.Peanut allergies, specifically, are rising — and as the Mayo Clinic points out, “Peanut allergy is 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, a 25-year-old with a nut allergy died of anaphylactic shock after eating cookies that didn’t list peanuts on the label, and last year, a man from Texas died after 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 product Fast Track status, which expedites its release to the public.
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