Weight-Based Dosing Informs Age Removal for Epinephrine Nasal Spray, With Nicole Chase, MD

The US Food and Drug Administration’s removal of the minimum age requirement for the 1 mg epinephrine nasal spray (neffy) aligns the product with weight-based dosing used across other epinephrine formulations, such as autoinjectors. The updated label, announced by ARS Pharmaceuticals on March 27, 2026, now allows use in any patient weighing ≥ 33 pounds.1,2

“The drug works in patients regardless of the age requirement,” Nicole Chase, MD, an allergist/immunologist at St. Paul Allergy & Asthma and associate professor of medicine at the University of Minnesota Medical School, told HCPLive. “It's really a weight-based drug, and… it's kind of strange that [the age requirement] was there in the first place.”

Chase noted the decision did not rely on dedicated studies in children younger than 4 years old. Instead, regulators reviewed available pharmacokinetic and pharmacodynamic data and applied an approach similar to injectable epinephrine, which has historically been dosed according to weight.

With expanded labeling, Chase emphasized clinician-led education to minimize adverse effects, particularly during initial use. She recommends hands-on training with demonstration devices during clinic visits.

Proper technique, particularly avoiding sniffing during delivery, may improve tolerability. Chase typically recommends observing patients for approximately 1 hour after administration to monitor response and potential reactions.

If symptoms persist, Chase advises administering a second dose in the same nostril, reflecting study findings showing improved response with this approach. She also recommends emergency evaluation if repeat dosing is required.

Insurance coverage and cost remain considerations, though access programs may help reduce out-of-pocket expenses. Chase described a program that uses a third party to get an epinephrine nasal spray. Overall, she said that the epinephrine nasal spray is doing a job in getting into patients’ hands.

“I’m so glad that the FDA has decided to streamline things,” Chase said. “We already struggle as clinicians…with reassuring parents that epi is safe…effective…[and] the number 1 therapy for a severe allergic reaction like anaphylaxis. Anytime the FDA can remove barriers to making people worry that, ‘oh, is this different somehow? Is this not as good?’ I think that always helps our cause as prescribers to really let them focus on if you even think you need it, just go ahead and take it. Removing that age requirement really just allows us to prescribe like we've been prescribing for other epinephrine devices.”

Part 1 of the interview with Chase can be watched here.

Relevant disclosures for Chase include GENZYME CORPORATION, Regeneron Healthcare Solutions, Incyte Corporation, Novartis Pharmaceuticals, Blueprint Medicines Corporation, Genentech USA, and AstraZeneca Pharmaceuticals.

References

1. ARS Pharmaceuticals, Inc. ARS Pharmaceuticals Receives FDA Approval to Remove Age Requirement From neffy® 1 mg (epinephrine nasal spray) Label. GlobeNewswire News Room. Published March 27, 2026. Accessed March 27, 2026. https://www.globenewswire.com/news-release/2026/03/27/3263722/0/en/ARS-Pharmaceuticals-Receives-FDA-Approval-to-Remove-Age-Requirement-From-neffy-1-mg-epinephrine-nasal-spray-Label.html

2. Campbell P. FDA Removes Age Requirement for Epinephrine Nasal Spray, Now Based on Weight Alone. HCPLive. March 27, 2026. Accessed April 9, 2026. https://www.hcplive.com/view/fda-removes-age-requirement-for-epinephrine-nasal-spray-now-based-on-weight-alone.