Neffy 1 mg now available for anaphylaxis is pediatric patients | Image Credit: © MQ-Illustrations - © MQ-Illustrations - stock.adobe.com.

On May 7, 2025, ARS Pharmaceuticals announced that epinephrine nasal spray (neffy) is available via prescription to US-patients aged 4 years and older who weigh 33 to < 66 lbs to treat Type I allergic reactions, including anaphylaxis.¹

The announcement follows the March 6, 2025, FDA expanded approval of neffy to include the younger patient population, which made the nasal spray the first and only needle-free epinephrine treatment indicated for younger children, according to previous coverage from Contemporary Pediatrics. The announcement aligns with ARS' initial availability announcement, which was slated for the end of May. Neffy was first approved on August 9, 2024 for children at a weight of at least 66 lbs.²

The spray is designed to be "easy-to-use" according to ARS, as the treatment can be carried in a backpack or lunchbox. The pharmaceutical company stated that 100% of users in human factor studies were able to dose neffy successfully, compared with up to 35% error rates with epinephrine injection devices. With a shelf life of 24 months and the ability to tolerate temperatures up to 122 degrees fahrenheit for up to 3 months, the recently approved spray offers flexibility compared to epinephrine injections.¹

"Many children fear needles, which can lead parents to delay administering needle-based epinephrine treatments. This delay may result in serious consequences," said Eric Karas, chief commercial officer, ARS Pharma, in a statement. "Many children fear needles, which can lead parents to delay administering needle-based epinephrine treatments. This delay may result in serious consequences."

"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 Russell Libby, MD, FAAP, founder and president of Virginia Pediatric Group, in a previous interview with Contemporary Pediatrics published after neffy was originally approved. "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," added Libby, who is also a member of the Contemporary Pediatrics editorial advisory board.²

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.

Panel discussion on neffy in pediatrics

In March, Contemporary Pediatrics published a panel discussion about the FDA approval of neffy and its role in allergic reactions.³

Panelists include:

Brian Schroer, MD, is an allergist-immunologist at the Cleveland Clinic Children's Hospital. Board-certified in internal medicine, pediatrics, and allergy and immunology, Schroer serves as the moderator for this panel discussion.

Colleen Kraft, MD, is a clinical professor of Pediatrics at the Keck School of Medicine of USC and an attending physician at the Children’s Hospital Los Angeles. In addition to these roles, Kraft is also the former president of the American Academy of Pediatrics.

Russell Traister, MD, is a pediatric allergy and immunology specialist at Allegheny Health Network’s Pediatric Institute. Board certified in allergy, immunology, and internal medicine, Traister serves as the third panelist for our discussion.

To watch the discussion, click here.

References:

1. ARS Pharmaceuticals’ neffy® (epinephrine nasal spray) 1 mg is Now Available in the United States for Type I Allergic Reactions, including Anaphylaxis, in Pediatric Patients Weighing 15 to < 30 Kilograms. ARS Pharma. Press release. May 7, 2025. Accessed May 7, 2025. https://www.globenewswire.com/news-release/2025/05/07/3076085/0/en/ARS-Pharmaceuticals-neffy-epinephrine-nasal-spray-1-mg-is-Now-Available-in-the-United-States-for-Type-I-Allergic-Reactions-including-Anaphylaxis-in-Pediatric-Patients-Weighing-15-t.html

2. Fitch, J. FDA approves neffy 1 mg for anaphylaxis in children aged 4 years and older. Contemporary Pediatrics. March 6, 2025. Accessed May 7, 2025. https://www.contemporarypediatrics.com/view/fda-approves-neffy-for-anaphylaxis-in-children-aged-4-years-and-older

3. Schroer B, Kraft C, Traister R. RX Review: The role of needle-free epinephrine in pediatric allergy for 2025. Contemporary Pediatrics. March 12, 2025. Accessed May 7, 2025. https://www.contemporarypediatrics.com/view/rx-review-the-role-of-needle-free-epinephrine-in-pediatric-allergy-for-2025