Key Takeaways

The device, referred to as neffy, is a nasal spray that delivers a dose of epinephrine through the nasal cavity instead of an intramuscular injection. This administration route makes giving the medication easier for parents, healthcare professionals, or anyone responding to an anaphylaxis emergency.

FDA approval of neffy has been delayed and iscurrently pending one more studyon its efficacy of repeat doses compared to repeat doses of other epinephrine products. But experts say its eventual approval will be a game-changer for people with severe allergies.

What Is Anaphylaxis?Anaphylaxisis a whole-body severe immune reaction to an allergen. It often involves life-threatening airway, breathing, and circulation complications that, while rare, can lead to death if untreated. Up to 5% of the U.S. population has experienced anaphylaxis at some point.The most common causes of anaphylaxis include:Food allergies (peanuts, tree nuts, eggs, seafood, etc.)Latex allergiesInsect bites and stingsMedications (antibiotics)

What Is Anaphylaxis?

Anaphylaxisis a whole-body severe immune reaction to an allergen. It often involves life-threatening airway, breathing, and circulation complications that, while rare, can lead to death if untreated. Up to 5% of the U.S. population has experienced anaphylaxis at some point.The most common causes of anaphylaxis include:Food allergies (peanuts, tree nuts, eggs, seafood, etc.)Latex allergiesInsect bites and stingsMedications (antibiotics)

Anaphylaxisis a whole-body severe immune reaction to an allergen. It often involves life-threatening airway, breathing, and circulation complications that, while rare, can lead to death if untreated. Up to 5% of the U.S. population has experienced anaphylaxis at some point.

The most common causes of anaphylaxis include:

Why a Needleless Epinephrine Treatment Is Needed

In addition to the lack of options, all autoinjectors on the market today contain a needle, which can create a barrier to use for people who are scared of needles.Lacerations and injuries are risks with administering needle-based autoinjectors. There have been reports of needles becoming embedded in skin after use, which can lead to pain and infection. The needle can also poke the finger of the person administering it.

How to Safely Use an EpiPen

The Burden of Food Allergies on Parents and Schools

The Centers for Disease Control and Prevention (CDC) reports that 1 in 13 U.S. children now have food allergies.There was a 50% increase in children diagnosed between 1997 and 2011.

This increase has put a burden on schools and parents to ensure children are not exposed to their food allergens at school. It requires training all staff on signs and symptoms of anaphylaxis, how to use an epinephrine autoinjector, and how to respond in case of an emergency.

A nasal option for treatment can reduce fear for parents and staff members who may be hesitant to use an autoinjector that contains a needle.

“A nasal spray version of the EpiPen would be huge for our school site,” Jennifer Brown, school nurse at a kindergarten through grade 8 school in California told Verywell Health. “We have many staff members that are hesitant to be trained because they are scared of needles. A nasal spray would eliminate a lot of those fears for both parents and staff.”

Op-Ed: I’m a School Nurse. Every Day Feels Like a ‘War Zone’

When Will Neffy Be Available?

In a meeting in May, the FDA Pulmonary-Allergy Drug Advisory Committee recommended that the FDA approve neffy. But the FDA Agency issued a Complete Response Letter in September. The agency asked manufacturer ARS Pharma to conduct an additional study to test repeat doses of neffy compared to repeat doses of an epinephrine injection under allergy-induced conditions.

With the new setback, ARS Pharma anticipates a resubmission of neffy to the FDA in the first half of 2024 after it completes the required study, and a launch of the product in the second half of 2024 if it does receive FDA approval.

“If proven to have the same efficacy with anaphylaxis as EpiPens, I would absolutely prescribe an alternative to my patients,” Patel said. “A lower price point would also be beneficial for patients.”

What This Means For You

6 Sources

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

Turner PJ, Jerschow E, Umasunthar T, Lin R, Campbell DE, Boyle RJ.Fatal anaphylaxis: mortality rate and risk factors.J Allergy Clin Immunol Pract. 2017;5(5):1169-1178. doi:10.1016/j.jaip.2017.06.031

American College of Allergy, Asthma, and Immunology.Anaphylaxis.

BioPharma Dive.How Mylan ended up with an EpiPen monopoly.

Centers for Disease Control and Prevention.Food allergies.

Food Allergy Research and Education.Facts and statistics.

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