The neffyinSchools program will supply eligible K-12 institutions with nasal spray doses for emergency treatment of severe allergic reactions.
RT’s Three Key Takeaways:
- Free Epinephrine Access: Eligible public and private K-12 schools in the US can receive two free cartons of neffy nasal spray starting in January 2025 for emergency treatment of severe allergic reactions.
- Needle-Free Administration: The nasal spray provides a needle-free alternative to traditional autoinjectors, which may help overcome needle anxiety and simplify medication delivery for school staff during emergencies.
- Undesignated Use Support: The program specifically addresses the 25% of school-based life-threatening reactions that occur in children with no previous allergy diagnosis by providing medication for undesignated use.
ARS Pharmaceuticals announced the planned launch of its neffyinSchools program, which will provide needle-free epinephrine to eligible public and private K-12 schools in the US at no cost.
The program, scheduled to begin in January 2025, allows qualifying schools to receive two cartons containing four single-use doses of neffy 2mg. This dose is currently approved by the Food and Drug Administration (FDA) for the treatment of Type I allergic reactions, including anaphylaxis, in adults and children weighing at least 30 kg (66 lbs). Participating schools will be eligible to receive replacement doses when the product is used or expires.
According to the company, studies indicate that 18% of children with food allergies experience a reaction while at school. Furthermore, 25% of severe reactions reported in school settings occur in children who had no prior diagnosis of a food allergy, according to data cited in the release.
“The potential for severe allergic reactions to food, medication, exercise, or insect bites can quickly result in an emergency if epinephrine is not available. Since many unexpected allergic reactions happen during the school day, readily available epinephrine is crucial,” said Richard Lowenthal, co-founder, president, and CEO of ARS Pharmaceuticals, in a news release.
Lowenthal also noted that neffy is easier for school staff to dispose of because it does not contain sharps and has a shelf life of 30 months.
Before the program launch, administrators are encouraged to review state laws regarding the stocking of epinephrine for undesignated use. While 49 states and Washington DC have legislation allowing schools to stock the medication, specific protocols may vary. Some schools may need to request modifications to state legislation to ensure personnel are protected from liability when using nasal spray products.
ARS Pharmaceuticals has also submitted a supplemental New Drug Application for a 1mg dose of neffy intended for children weighing between 33 and 66 lbs. The FDA has granted this application priority review with a target action date of March 6, 2025. If approved, this lower dose will also be made available to schools through the program to help healthcare coordinators manage a wider range of student needs.
The company will host a webinar on December 12 to provide information to school nurses and administrators regarding the program, training, and online resources. Following the official launch, ARS Pharmaceuticals will provide application instructions for schools to receive the medication.
