ARS launches program to provide free neffy in eligible K-12 schools | Image Credit: © JoxyAimages - © JoxyAimages - stock.adobe.com.

Epinephrine nasal spray (neffy; ARS Pharmaceuticals) could soon be on the shelves of various school nurses offices in the United States for use in emergency situations.¹

The potential comes from a program called neffyinSchools, recently launched by ARS Pharmaceuticals. According to an announcement from the pharmaceutical company, eligible K-12 schools, both public and private, in the United States have the opportunity to receive 4 single-use doses of neffy 2 mg for emergency use treatment of type I allergic reactions (included anaphylaxis) in adults and children who weigh 66 lbs (30 kg) or more.

Schools could receive neffy at no cost via the School Health Corp. SHConnect platform.

Neffy was approved by the FDA for the above indication on August 9, 2024, to become the first nasal spray to treat anaphylaxis. The approval provided an option for those with needle phobia, a fear that is so great in some patients that it could prevent receipt of a potentially life-saving care, according to the CDC.²

The single-dose nasal spray is administered into 1 nostril, with potential of a second dose administration if there is no improvement in symptoms, or if symptoms worsen.

“I think this [treatment] will just float way to the top as soon as it becomes an option and people are aware of it, and there are a number of reasons why," Russell Libby, MD, founder and president of the Virginia Pediatric Group and an assistant clinical professor of Pediatrics at the George Washington University School of Medicine and Health Sciences, previously told Contemporary Pediatrics.

"The first reason, to me, is that it is needle-free and it is a stable solution. When you look at EpiPens, you have a real narrow window of temperatures where it stays stable," said Libby. "Sometimes it can become impotent, but more often, the potency just diminishes.”

Type 1 allergic reactions can be caused by foods, insects, medication, exercise, or other unknown causes, and they can happen quickly. ARS noted in the announcement that approximately one-quarter of anaphylactic reactions in schools are among those with previously undiagnosed allergies.¹

"School nurses play a pivotal role in the health and wellbeing of students," said Kenneth Mendez, President and CEO of the Asthma and Allergy Foundation of America in a statement.

"Unexpected allergic reactions can happen at any time – including during the school day – so it is crucial to have epinephrine readily available to administer by nurses and other trained school officials," added Mendez. "The neffyinSchools program will help schools to obtain epinephrine free of cost. This positions schools to be ready to provide emergency treatment for severe allergic reactions."

Schools that are interested in applying to the program can do so at neffy.com/community-programs.

More on neffy

On January 13, ARS announced that a supplemental new drug application filed with the FDA for a 1 mg dose among those who weigh 33 to 66 lbs has been assigned a prescription drug user fee act date of March 6, 2025 for potential expanded approval.³

If approved, product availability is expected in the second quarter of 2025.

Click here for more on neffy, as well as initial FDA approval details and commentary.

References:

1. ARS Pharmaceuticals Launches neffyinSchools Program Providing Free Life-Saving Needle-Free Epinephrine For Emergency Use to Eligible K-12 Schools. ARS Pharmaceuticals. Press release. January 21, 2025. Accessed January 22, 2025. https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-launches-neffyinschools-program-providing

2. Fitch, J. 2024’s critical needle-free approvals for pediatric anaphylaxis, influenza. Contemporary Pediatrics. December 26, 2024. Accessed January 22, 2025. https://www.contemporarypediatrics.com/view/2024-s-critical-needle-free-approvals-for-pediatric-anaphylaxis-influenza

3. Fitch, J. PDUFA date set for neffy 1 mg for children who weigh 33 lbs or more. Contemporary Pediatrics. January 13, 2025. Accessed January 22, 2025. https://www.contemporarypediatrics.com/view/pdufa-date-set-for-neffy-1-mg-for-children-who-weigh-33-lbs-or-more