FDA Approves neffy 1 mg for Type 1 Allergic Reactions, Including Anaphylaxis, in Children

FDA officials approved epinephrine nasal spray 1 mg (neffy; ARS Pharmaceuticals) for the treatment of type 1 allergic reactions, including anaphylaxis, in children aged 4 years and older who weigh 15 to less than 30 kg. This marks the first significant innovation in epinephrine delivery for this patient population in more than 35 years, according to a news release.¹

Children as young as 10 years can use neffy | Image credit: Aycan | stock.adobe.com

The approval is based on data from extensive clinical trials, including pharmacokinetic and pharmacodynamic responses in children and adults that were consistent with those of epinephrine injection products. Adverse events in children were generally mild and transient.¹

Data from human factor studies show that children as young as 10 years can use neffy effectively by following instructions, and even untrained individuals such as babysitters or teachers can effectively administer neffy. The device has a shelf-life of 24 months at room temperature and tolerance to temperature exposures up to 122°F based on testing for up to 3 months. If accidentally frozen, neffy can be thawed without impact on the product quality and reliability.¹

“Many children and caregivers fear needle-based auto-injectors, which can delay lifesaving treatment,” said Richard Lowenthal, cofounder, president, and CEO of ARS Pharma, in a news release. “neffy’s needle-free, easy-to-use design addresses this unmet need, offering families a long-awaited alternative.”¹

The approval of the 1 mg dose and the August 2024 approval of a 2 mg dose support the neffyinSchools program, in which all public and private K-12 schools in the US are eligible to receive 2 cartons (4 single-use doses) of neffy as well as additional free doses when the product is used or expires. The program is only for undesignated use, and children with prescriptions for epinephrine must continue to supply medication to their school in accordance with state and school guidelines.²

Life-threatening, type 1 allergic reactions can happen quickly and be caused by foods, insects, medication, exercise, or other unknown causes. Approximately one-quarter of anaphylactic reactions in schools are among students with previously undiagnosed allergies, and data show that food allergy affects approximately 1 in 20 school-aged children.²

“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,” said Kenneth Mendez, president and CEO of the Asthma and Allergy Foundation of America, in a news release. “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.”²

Recent data demonstrating the efficacy of neffy following an oral food challenge were presented at the American Academy of Allergy, Asthma, and Immunology/World Allergy Organization Joint Congress from February 28 through March 3, 2025. In the study, a clinical trial of 15 patients aged 6 to 17 years with gastrointestinal, respiratory, or circulatory symptoms were included, alongside an additional 15 matched controls. All 15 patients in the neffy group received neffy as the initial treatment, and additional treatments included antihistamines, b₂-inhalation, and steroids. Intramuscular epinephrine was used for biphasic reaction.³

Baseline skin and gastrointestinal symptoms were observed in 12 cases each, and respiratory symptoms were observed in 21 cases. Patients receiving neffy had fewer skin symptoms at 15, 20, and 30 minutes and respiratory symptoms at 5, 10, and 15 minutes post-treatment compared with the control group. The neffy group also experienced fewer gastrointestinal symptoms at 5, 10, and 15 minutes. Total symptom scores were lower in the neffy group at 10 and 15 minutes.³

“The availability of a needle-free epinephrine option for children is a breakthrough in the treatment of severe allergic reactions,” said David Fleischer, MD, section head of allergy and immunology at Children’s Hospital Colorado, in a news release. “Many people wait to administer epinephrine until symptoms progress or take antihistamines as a first line of defense because they are afraid of injection. Neffy’s small, user-friendly design addresses these challenges, empowering people to actually carry epinephrine and act quickly and confidently during an allergic emergency. This innovation will likely significantly improve health outcomes and enhance quality of life.”¹

REFERENCES

1. ARS Pharmaceuticals announces FDA approval of neffy 1 mg (epinephrine nasal spray) for type I allergic reactions, including anaphylaxis, in pediatric patients weighing 15 to <30 kilograms. News release. ARS Pharma. March 5, 2025. Accessed March 6, 2025. https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-announces-fda-approval-neffyr-1-mg

2. ARS Pharmaceuticals launches neffyinSchools program providing free life-saving needle-free epinephrine for emergency use to eligible K-12 schools. News release. ARS Pharma. January 21, 2025. Accessed March 6, 2025. https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-launches-neffyinschools-program-providing

3. Takahashi K, Takahashi K, Yanagida N, et al. Superior efficacy of epinephrine nasal spray for the relief of symptoms following an oral food challenge. J Allergy Clin Immunol. 2025;155(2).