
U.S. schools may be able to receive neffy epinephrine nasal sprayers at no cost for use in allergy emergencies. ARS Pharmaceuticals, the manufacturer, recently launched the program, called neffyinSchools. It offers the free medication to K-12 schools across the United States.
“We are deeply committed to ensuring neffy is freely available to all eligible K-12 schools, providing life-saving epinephrine for emergency situations without fear or hesitation,” says Richard Lowenthal, ARS Pharma’s president and CEO.
However, getting neffy into schools may first require changes to state laws known as “stock epinephrine” laws. Nearly all states have passed laws allowing or requiring epinephrine auto-injectors to be kept on hand in schools – for use in anyone during an allergy emergency. But the laws, written before a nasal spray was available, typically specify “auto-injectors.”
Rewrites will be needed to allow nasal epinephrine, Lowenthal notes. He hopes that launching the free medication program will spark legislatures to move quickly.
“We believe by offering the program now, even though a lot of these laws are not adjusted, it will encourage the states to change their laws more quickly,” he says.
School nurse associations are showing support for this effort. School nurses are very interested in a nasal sprayer as an alternative to a needle-based device, according to Lowenthal. More than 1,000 school nurses signed up for a neffy online training webinar in December. Then another 4,200 registered for January’s webinar.
“The nurses want to get neffy into the schools. They really prefer it,” Lowenthal says. “They hopefully will push the legislatures.”
The U.S. Food and Drug Administration approved neffy, the first needle-free alternative to epinephrine auto-injectors, for those who weigh over 66 pounds in August 2024. The nasal spray treats allergic reactions, including severe reactions known as anaphylaxis, caused by food, drug or stinging insect allergies.
The Need for Epinephrine at School
About 1 in 13 U.S. children have food allergies. Accidental exposures among children at schools happen all too often. A committee report for the American Academy of Allergy, Asthma and Immunology (AAAAI) says 29 percent of cases of anaphylaxis in kids take place at school or daycare.
Allergists advise the parents of children at risk of anaphylaxis to make sure their kids have a prescription for two epinephrine auto-injectors, or now, the nasal sprayer, while at school. Children who are old enough may carry their own medication, or it’s kept in the classroom or a nurse’s office.
Yet not every parent follows through on sending a prescription to school. And the AAAAI committee says between 15 and 31 percent of anaphylaxis episodes in schools involve students without a previously known allergy. Delays in administering epinephrine have been linked to both poor outcomes and fatalities.
Incidents such as these and the work of food allergy advocates have led 49 states (Hawaii is the exception) to pass “stock epinephrine laws.” These laws allow K-12 schools to keep auto-injectors on hand during emergencies. This helps to ensure quick access to the life-saving medications for anyone at school, not only those with an individual prescription. About 10 states “require” schools to have stock epinephrine.
Neffy Alternative and School Laws
The effort to amend laws or regulations to allow nasal epinephrine is already underway in several states.
In September 2024, Massachusetts state officials authorized the use of all FDA-approved, pre-dosed forms of epinephrine, including neffy, in schools. There, a change in the law may not be needed, Lowenthal says.
Neffy is also allowed in Maine, Wisconsin and New York schools.
On January 13, a bill was introduced in the California legislature to amend its stock epinephrine law, called Zacky’s Food Allergy Safety Treatment Act. The new law will require schools to stock “at least one type of FDA-approved emergency epinephrine system.”
Kenneth Mendez, president and CEO of the Asthma and Allergy Foundation of America, says getting stock nasal epinephrine into the schools will “provide another quick, safe option for delivering potentially life-saving medication.” His organization plans to advocate for changes to state laws to provide access to all FDA-approved forms of the epinephrine.
“An epinephrine nasal spray such as neffy offers choice in terms of how epinephrine is administered,” Mendez says. “In a case of anaphylaxis, the bottom line is epinephrine should be available and administered quickly.”
How Can Schools Get Free Neffy?
ARS Pharma can provide stock nasal epinephrine only to schools in states where the laws or regulations allow it. “They need to have those laws adjusted so we can supply them with the neffy,” Lowenthal says. Once that’s so, they can apply for the program here.
Public and private K-12 schools can request two free packages, for a total of four doses. Neffy comes in packages of two sprayers, each a 2-milligram single-spray dose. Schools can also request replacements when their medication expires.
Epi Spray Sales; Device for Smaller Kids
ARS Pharma has also applied to the FDA for approval of a 1-mg sprayer for smaller children, weighing 30 to 66 pounds. The FDA’s decision on the lower dose neffy is expected by March 6, 2025.
Lowenthal says the 1-mg dose should be available within a few weeks of getting the OK from the FDA.
In the first few months after neffy 2-mg product became available in the fall of 2024, demand was high, the CEO says. From October to December 2024, 14,500 prescriptions were filled. More than 3,000 allergists and other healthcare providers have prescribed neffy to patients.
Early “sales have exceeded expectations,” Lowenthal says.
Availability in UK, Canada and Europe
ARS Pharma has also filed for approval of its 2-mg sprayer in Canada and the United Kingdom. In Canada and the U.K., it will be called EURneffy and sold by ALK-Abelló A/S, a pharmaceutical firm headquartered in Denmark.
An approval decision is expected in the U.K. this summer, and by the end of 2025 in Canada, Lowenthal says.
In August 2024, the European Commission approved the 2-mg EURneffy for the emergency treatment of allergic reactions in the European Union. In March, the company plans to file for European approval of the 1-mg sprayer.
Related Reading:
Neffy Epi Sprayers Available in U.S. Pharmacies and Online
Allergic Living’s Guide: All About Epinephrine