FDA approves neffy 1 mg for anaphylaxis in children aged 4 years and older

FDA approves neffy for anaphylaxis in children aged 4 years and olderLatest revision | Image Credit: © Calin - © Calin - stock.adobe.com.

As of March 5, 2025, epinephrine nasal spray (neffy; ARS Pharmaceuticals) 1 mg is FDA approved to treat type I allergic reactions, including anaphylaxis, in children aged 4 years and older who weigh 33 to 66 lbs, according to an announcement from ARS Pharmaceuticals.¹

With the approval, neffy becomes the first and only needle-free epinephrine treatment indicated for younger children. The expanded indication into a younger population comes after the August 9, 2024, initial approval of neffy for adults and pediatric patients who weigh at least 66 lbs.^1,2

Neffy 1 mg is expected to be available in the United States by the end of May 2025, stated ARS in the announcement.¹

“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 & Immunology and professor of Pediatrics at Children's Hospital Colorado, in a statement.¹

"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," said Fleischer.

According to ARS, approval of neffy 1 mg is based on pharmacokinetic and pharmacodynamic responses in both pediatric and adult patients that were consistent with epinephrine injection products. ARS noted children as young as 10 years of age can use neffy effectively by following instructions, based on human factor studies.

With a shelf-life of 24 months at room temperature, and the tolerance to temperature exposures up to 122°F (50°C) on testing up to 3 months, neffy offers potency benefits for a longer period compared to EpiPens, according to a Contemporary Pediatrics board member, Russell Libby, MD, FAAP.^1,3

"When you look at EpiPens, you have a real narrow window of temperatures where it stays stable. What does that mean? Well, sometimes it can become impotent, but more often, the potency just diminishes," said Libby, founder and president of Virginia Pediatric Group, in a previous interview with Contemporary Pediatrics published after neffy was originally approved.³

"So you might get 90% or 70%, whatever it is. I don't think we have a lot of data on it, but we know that it is very specific to be stored within basically room temperature 60 to 90 degrees,” Libby explained. In contrast, neffy remains stable even in extreme conditions, providing a more reliable option for patients.

The approval of neffy 1 mg comes nearly 2 months ARS announced in a financial report that a supplemental new drug application was filed with the FDA for younger indication. Neffy was approved a day early of the March 6, 2025 Prescription Drug User Fee Act target action date.¹

"Today’s FDA approval of neffy 1 mg marks a major milestone towards our efforts to transform the management of severe allergic reactions,” said Richard Lowenthal, president and CEO of ARS, in a statement.

"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," added Lowenthal. "With nearly 4 out of 10 US 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.”

In an effort to place neffy on the shelves of various school nurses offices in the United States, eligible schools could receive neffy through the neffyinSchools program from ARS, launched in January 2025, based on availability.⁴

READ MORE: ARS launches program to provide free neffy in eligible K-12 schools

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. ARS Pharmaceuticals. 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. Fitch, J. FDA approves neffy as first nasal spray to treat anaphylaxis. Contemporary Pediatrics. August 9, 2024. Accessed March 6, 2025. https://www.contemporarypediatrics.com/view/fda-approves-neffy-as-first-nasal-spray-to-treat-anaphylaxis

3. Fitch, J. Discussing FDA approved neffy with Russell Libby, MD, FAAP. Contemporary Pediatrics. January 1, 2025. Accessed March 6, 2025. https://www.contemporarypediatrics.com/view/discussing-fda-approved-neffy-with-russell-libby-md-faap

4. Fitch, J. ARS launches program to provide free neffy in eligible K-12 schools. Contemporary Pediatrics. January 22, 2025. Accessed March 6, 2025. https://www.contemporarypediatrics.com/view/ars-launches-program-to-provide-free-neffy-in-eligible-k-12-schools