FDA Approves Neffy 1 mg Epinephrine Nasal Spray, Only Needle-Free Treatment for Patients Weighing Less Than 30 kg

Neffy 1 mg

© ARS Pharma

The US Food and Drug Administration (FDA) approved neffy 1 mg (epinephrine nasal spray), marking the first and only needle-free epinephrine treatment indicated for pediatric patients weighing 15 to <30 kg, according to an ARS Pharmaceuticals news release.¹

This approval represents the first significant advancement in epinephrine delivery for younger children in more than three decades. Neffy was first approved by the FDA in August 2024 for patients who weight more than 15 kg.²

“Today’s FDA approval of neffy 1 mg marks a major milestone towards our efforts to transform the management of severe allergic reactions,” says Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma. “Many children and caregivers fear needle-based auto-injectors, which can delay lifesaving treatment. neffy’s needle-free, easy-to-use design addresses this unmet need, offering families a long-awaited alternative. With nearly four out of 10 U.S. epinephrine prescriptions written for children under the age of 18 — and nearly a third of those for children weighing 15 to 30 kilograms4 — we believe neffy 1 mg will improve access to a needle-free option for the treatment of severe allergies and reduce hesitation in treating this vulnerable group. It will also eliminate risks like accidental needle injuries to children or caregivers.”¹

The newly approved nasal spray is designed to address the well-documented concerns many caregivers and pediatric patients have with needle-based auto-injectors, including needle anxiety and accidental needlestick injuries. ARS Pharmaceuticals reports that nearly 40% of patients delay lifesaving epinephrine treatment, often due to fear or reluctance surrounding needle use. By eliminating the needle, neffy seeks to foster earlier intervention in severe allergic reactions (type I), including anaphylaxis, and ultimately improve patient outcomes.¹

“The availability of a needle-free epinephrine option for children is a breakthrough in the treatment of severe allergic reactions,” says Dr. David Fleischer, Section Head of Allergy & Immunology, and Professor of Pediatrics, at Children’s Hospital Colorado. “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

Clinical data presented by ARS Pharmaceuticals indicate that pharmacokinetic and pharmacodynamic responses to this nasal formulation are consistent with those produced by epinephrine injection products in both adult and pediatric populations. In pediatric trials, adverse events were generally mild and resolved without additional intervention. Human factor studies suggest children as young as 10 years of age can self-administer the drug when following instructions. Untrained individuals, such as teachers or babysitters, have also demonstrated the ability to administer the medication effectively.

The company anticipates that neffy 1 mg will be available in the United States by the end of May 2025.

According to ARS Pharmaceuticals, neffy 1 mg features several practical benefits, including a 24-month shelf life at room temperature and tolerance for elevated temperatures up to 122°F (50°C) based on testing for up to three months. Additionally, the product remains usable if it has been accidentally frozen and then thawed.

A broad access and affordability program, called neffyConnect, aims to minimize cost barriers by offering co-pay savings that can reduce out-of-pocket expenses for most commercially insured patients to as little as $25 for two single-use devices. A patient assistance program is also available for certain uninsured or underinsured individuals who meet eligibility requirements. In addition, ARS Pharmaceuticals indicates that qualified schools may receive neffy 1 mg via the neffyinSchools program, which could help institutions maintain an on-site supply for pediatric emergencies.

Neffy is indicated for the emergency treatment of type I allergic reactions, including anaphylaxis, in adults and children aged 4 years and older who weigh ≥15 kg (33 lb). Each nasal spray contains a single dose of epinephrine and should be used immediately once an allergic reaction is recognized. If symptoms persist or worsen, a second dose should be administered with a new device 5 minutes after the first. As with any anaphylactic episode, users should seek further medical care immediately following administration.¹

Reference

1. ARS Pharmaceuticals. 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. Published March 5, 2025. Accessed March 5 2025. https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-announces-fda-approval-neffyr-1-mg
2. Halsey, Grace. FDA approves first intranasal epinephrine for emergency treatment of allergic reactions. PatientCareOnline website. Accessed March 6, 2025. https://www.patientcareonline.com/view/fda-approves-first-intranasal-epinephrine-for-emergency-treatment-of-allergic-reactions