FDA Removes Age Restriction for neffy 1 mg, Expanding Access to Needle-Free Epinephrine

The FDA has approved a labeling update for epinephrine nasal spray 1 mg (neffy; ARS Pharmaceuticals, Inc) that removes the minimum age requirement, allowing use based solely on weight in patients experiencing type 1 allergic reactions, including anaphylaxis.¹ This update expands access to a needle-free epinephrine option, particularly for younger pediatric patients who previously met weight criteria but were excluded due to age restrictions.

Transition to Weight-Based Dosing

Neffy was initially approved as the first needle-free epinephrine option for allergic reactions, offering an alternative to traditional autoinjectors.² Under prior labeling, the 1-mg dose was indicated for pediatric patients aged 4 and older who weighed between 33 lbs (15 kg) and less than 66 lbs (30 kg).^1,2

With the updated label, the FDA has removed the age requirement, allowing all patients weighing at least 33 lbs to receive neffy 1 mg regardless of age.¹ This shift aligns with standard pediatric dosing practices, which often rely on weight rather than age, and helps address a gap in access for younger children.

Notably, approximately one-fourth of patients in the 33- to 66-lb weight range are younger than 4 years, highlighting the clinical relevance of this change.^1,3 By eliminating the age cutoff, the FDA has expanded eligibility for a population at risk for severe allergic reactions but previously unable to receive this formulation.

Addressing Barriers to Epinephrine Administration

Anaphylaxis is a rapid-onset, life-threatening condition that requires immediate epinephrine administration. Despite this, delays in treatment remain common. Fear of needles—both in children and caregivers—has been identified as a key barrier to the timely use of epinephrine autoinjectors.³

Neffy’s intranasal delivery system may help mitigate these concerns. Experts note that caregivers often hesitate to administer injectable epinephrine due to concerns about causing pain or accidental self-injection.³ The availability of a needle-free option may improve confidence and encourage faster intervention, which is critical in emergency situations.

Additional Label Updates and Practical Considerations

In addition to removing the age restriction, the updated labeling includes several practical enhancements to improve usability. The FDA now recommends storing neffy in its blister packaging or a designated carrying case, which will be included with prescriptions beginning in summer 2026.^1,3

The revised label also introduces more flexible guidance for handling and storage. For example, neffy may still be used if it has been accidentally frozen and subsequently thawed, and it can tolerate temperature excursions up to
122 °F.³ These updates are particularly relevant for real-world settings such as schools, daycare centers, and outdoor environments.

Neffy is available in 2 strengths: a 1-mg dose for patients weighing 33 to 66 lbs, and a 2-mg dose for those weighing 66 lbs or more.^1,2 As with other epinephrine products, patients are advised to carry 2 doses in case symptoms persist or recur.³

Implications for Pharmacists

Pharmacists play a central role in ensuring the appropriate use of epinephrine products and in educating caregivers to recognize and manage anaphylaxis. Removing the age requirement simplifies prescribing criteria and may facilitate broader adoption of neffy in pediatric populations.

Counseling should emphasize proper administration technique, the importance of prompt use at the first sign of anaphylaxis, and the need for emergency follow-up care. Pharmacists can also help clarify that eligibility for neffy 1 mg is now determined by weight rather than age, reducing confusion during high-stress situations.

Overall, this FDA labeling update represents a meaningful advancement in improving access to epinephrine and addressing long-standing barriers to its timely administration, particularly among younger children at risk for severe allergic reactions.

REFERENCES

1. ARS Pharmaceuticals receives FDA approval to remove age requirement from neffy 1 mg (epinephrine nasal spray) label. News release. ARS Pharmaceuticals, Inc. 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. Antrim A. FDA Approves neffy 1 mg for type 1 allergic reactions, including anaphylaxis, in children. Pharmacy Times. March 6, 2025. Accessed March 27, 2026. https://www.pharmacytimes.com/view/fda-approves-neffy-1-mg-for-type-1-allergic-reactions-including-anaphylaxis-in-children

3. Campbell P. FDA removes age requirement for epinephrine nasal spray, now based on weight alone. HCP Live. March 27, 2026. Accessed March 27, 2026. https://www.hcplive.com/view/fda-removes-age-requirement-for-epinephrine-nasal-spray-now-based-on-weight-alone