FDA Removes Age Restriction for Epinephrine Nasal Spray, With Nicole Chase, MD

The US Food and Drug Administration (FDA) recently eliminated the minimum age requirement for the 1 mg epinephrine nasal spray (neffy), allowing prescribing decisions to be guided by patient weight rather than age. The updated labeling now permits use in any patient weighing ≥ 33 pounds.1,2

“We’ve been giving epinephrine safely to younger…and really lower-weight children for a long time,” said Nicole Chase, MD, an allergist/immunologist at St. Paul Allergy & Asthma and associate professor of medicine at the University of Minnesota Medical School. “Now [that] neffy can be prescribed for children that are 33 to 66 pounds in the 1 mg strength, it just mirrors what we've been used to doing for epinephrine auto injectors for the 0.15 mg strength.”

ARS Pharmaceuticals announced the FDA’s approval of the labeling update on March 27, 2026. Before the change, epinephrine nasal spray was indicated for pediatric patients aged ≥ 4 years who met weight-based criteria (1 mg for ≥33 lbs to <66 lbs; 2 mg for ≥66 lbs).

The updated label now guides use, temperature, and storage. A patient should avoid sniffing during dosing. Chase explained that inhaling deeply during delivery has been associated with most reported adverse effects.

“I encourage people to just breathe in through their nose, hold the device so that their fingers actually touch the outside nostrils, and then just depress the plunger so that they don't accidentally sniff when they administer it,” she said.

If a patient inadvertently sniffs after nasal administration, the label states to continue the care as normal. A patient does not need a second dose if symptoms improve within 5 minutes.

The updated label provides reassurance for families worried about environmental exposure. The nasal spray can tolerate brief temperature changes, including freezing followed by thawing, and short periods of heat exposure up to 122°F.

“I like to say, if you're comfortable, it's comfortable,” Chase said.

Counseling families on storage remains essential, she added. The label states that the device should be kept in its blister packaging or carrying case and stored at room temperature whenever possible. ARS Pharmaceuticals announced it plans to provide a carrying case with each prescription at no cost beginning this summer; the case is designed to hold 2 devices.

Chase also highlighted the longer shelf life of the nasal spray compared with many injectable epinephrine products, which may reduce the burden of frequent replacement. Intranasal epinephrine can also reduce needle anxiety.

She added that the availability of multiple delivery options allows clinicians to tailor recommendations to individual circumstances. For example, intranasal epinephrine may be particularly helpful for children attending camps, spending time outdoors, or in school settings where storage and usability are concerns.

In clinical practice, Chase has administered intranasal epinephrine during supervised food challenges and observed favorable tolerability among pediatric patients.

The removal of the age restriction may ultimately improve treatment adherence, which remains a significant challenge in anaphylaxis management. Chase emphasized that increasing comfort and accessibility could encourage earlier use of epinephrine during allergic reactions. She stressed that epinephrine remains safe and effective, and delays in administration pose greater risks than unnecessary use.

“If a [child] even think[s] they're having a reaction, I really want them to go ahead and take epinephrine,” Chase said. “I like to say that they can just ask for forgiveness instead of asking for permission. Epi is safe and effective, and it really prevents the bad [food allergy] outcomes.”

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.