The US Food and Drug Administration (FDA) has approved a labeling update for neffy 1 mg (epinephrine nasal spray) eliminating a previous minimum age requirement for pediatric patients, according to an announcement from ARS Pharmaceuticals, Inc. on March 27, 2026.
The updated indication now permits use of the 1 mg formulation for type I allergic reactions in any patient who weighs 33 lbs (15 kg) or more, without an age floor. A diversion from the March 2025 approval, which indicated the agent for patients aged 4 years and older meeting the same weight requirment.
"Severe allergic reactions are a major concern in early childhood and parents often delay treatment because they are afraid of hurting their child with a needle-injector or accidentally injecting themselves,” said Nicole Chase, MD, an allergist and immunologist at St. Paul Allergy and Asthma as well as an associate professor of medicine at the University of Minnesota Medical School. “Having a needle-free epinephrine treatment available for anyone who meets the weight criteria is an important step forward, in broadening access, lowering treatment hurdles, and supporting caregivers who are doing everything they can to protect their children.”
According to the company, the revision addresses a clinically meaningful gap, with approximately 25% of pediatric patients in the weight range of ≥33 lbs and <66 lbs who may require epinephrine are younger than 4 years of age.¹ For this subset of patients, the prior label had excluded access to the 1 mg nasal spray formulation solely on the basis of age, independent of weight-based dosing rationale.
Regulatory Overview
The FDA's action constitutes a supplemental labeling approval, updating the prescribing information for epinephrine nasal spray 1 mg to remove age criteria from the indication. The drug remains indicated for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 33 lbs or greater.
The 1 mg dose is specified for patients weighing ≥33 lbs and <66 lbs (15 kg to <30 kg), and the 2 mg formulation remains the recommended dose for patients weighing 66 lbs (≥30 kg) or more.¹
Additional label revisions approved concurrently include updated guidance on several practical use scenarios. The revised labeling clarifies if a patient inadvertently sniffs after nasal administration, clinical management proceeds the same as without sniffing, and if symptoms improve within 5 minutes, a second dose is not required.
The label also now permits use of epinephrine nasal spray if accidentally frozen and subsequently thawed, and specifies brief temperature excursions up to 122°F are acceptable.¹ These updates may have practical implications for real-world storage and use, particularly in school, childcare, or outdoor settings.
The company also announced updated storage recommendations, advising epinephrine nasal spray be carried in its original blister packaging or in a dedicated carrying case. ARS Pharmaceuticals indicated it currently provides a carrying case—designed to hold two devices—at no charge, and plans to include one with each prescription carton beginning in summer 2026.¹
Clinical Context
Anaphylaxis is a rapid-onset, potentially fatal systemic hypersensitivity reaction requiring immediate epinephrine administration. Type I allergic reactions, which include anaphylaxis, can be triggered by foods, insect stings or bites, medications, exercise, and other allergens, and may progress to life-threatening cardiovascular and respiratory compromise within minutes.¹
Epinephrine remains the only FDA-approved first-line treatment for anaphylaxis. Despite this, adherence to carrying prescribed epinephrine and willingness to administer it in an emergency remain problematic at a population level. According to data cited by ARS Pharmaceuticals from the IQVIA MIDAS database, approximately 20 million individuals in the United States have been diagnosed and treated for severe Type I allergic reactions over the past 3 years, yet in 2023 only 3.2 million filled an active epinephrine auto-injector prescription.¹ Of those, approximately half did not consistently carry their device, and among those who did carry it, more than half either delayed or failed to administer it when needed.¹
Needle fear, device complexity, and concerns about accidental self-injection have been cited in published literature as contributing factors to delayed or withheld epinephrine administration. The availability of a needle-free delivery route has been proposed as a potential strategy to address these barriers, though the clinical equivalence of intranasal versus intramuscular epinephrine delivery, particularly in very young children, warrants continued scrutiny.
Drug and Drug-Class Background
Epinephrine nasal spray was developed as an intranasal formulation designed to deliver epinephrine via the nasal mucosa without the need for injection. The product received its initial FDA approval for the emergency treatment of Type I allergic reactions, including anaphylaxis, in adult and pediatric patients weighing ≥33 lbs, with the original 1 mg label specifying a minimum age of 4 years for pediatric patients in the lower weight tier.¹ The 2 mg formulation is approved for patients weighing ≥66 lbs.
The removal of the age restriction from the epinephrine nasal spray 1 mg label represents an incremental but potentially meaningful regulatory step, particularly for families of children under 4 years who fall within the approved weight range. Weight-based dosing is well-established in pediatric pharmacology, and the FDA's decision to align the indication with weight criteria alone, rather than maintaining a combined weight-and-age threshold, reflects a biologically coherent approach to dosing in this population.
“This is a major advancement for the families with small children who live with the constant worry of severe allergic reactions in their youngest children,” said Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma.
References
- 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
- Campbell P. FDA Approves 1 mg neffy Nasal Spray for Pediatric Anaphylaxis. Hcplive.com. Published March 6, 2025. Accessed March 27, 2026. https://www.hcplive.com/view/fda-approves-1-mg-neffy-nasal-spray-for-pediatric-anaphylaxis
