Neffy Update: FDA to Review 1 mg Version in First Quarter 2025, for Young Children with Type 1 Allergic Reactions

ARS Pharmaceuticals had a big year in 2024: The company won US Food and Drug Administration (FDA) approval in August for neffy (epinephrine nasal spray), the first alternative to epinephrine delivered via manual syringe for emergency treatment of type 1 allergic reactions, including anaphylaxis.1

In 2025, ARS has its sights set on expanding neffy’s reach into pediatric populations. The company submitted a supplemental New Drug Application (sNDA) for a 1 mg for children who weigh 15 to 30 kg in September 2024.1

In a January 13, 2025, news release explaining the company’s financial performance and strategic goals, the company revealed that neffy for pediatric use has a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2025, and if all goes well, the 1 mg product would be available by the second quarter of 2025.2

“Looking ahead to 2025, we are poised to accelerate the growth of neffy through targeted commercial initiatives, including advancing education and awareness among our key prescribers, achieving over 80 percent commercial insurance coverage and launching impactful direct-to-consumer marketing campaigns for the neffy brand,” said Richard Lowenthal, President and CEO of ARS Pharma, in the news release. “Neffy is transforming the lives of patients by offering a simple, effective, and life-saving treatment option, and we are very pleased to be making such a meaningful difference in the lives of patients, families and caregivers.”2

More than 40% of the 6 million US children with food allergies have experienced an anaphylactic-like allergic reaction, according to ARS Pharma. Traditional injected epinephrine, while clinically effective, tend to frighten pediatric patients. Needles frighten 2 out of 3 children and more than 50% of parents self-report fear about using their child’s potentially life-saving epinephrine autoinjector. Approval of neffy 1 mg would be “the first new delivery method for [young children] in more than 35 years,” Lowenthal said in a September 2024 news release.1

References

1. sNDA Goes to FDA for neffy 1 mg for Young Children with Type 1 Allergic Reactions. Patient Care Online. Published September 11, 2024. Accessed January 13, 2025. https://www.patientcareonline.com/view/snda-goes-to-fda-for-neffy-1-mg-for-young-children-with-type-1-allergic-reactions
2. ARS Pharmaceuticals Announces Preliminary Fourth Quarter 2024 Financial Results and 2025 Objectives for neffy (epinephrine nasal spray). Published January 13, 2025. Accessed January 13, 2025. https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-announces-preliminary-fourth-quarter-2024