FDA Removes Age Requirement for neffy

The FDA approved removing the age requirement for epinephrine nasal spray (neffy) 1 mg, effectively allowing all children and adults who weigh 33 pounds or more to utilize the needle-free treatment for emergency allergic reactions. This regulatory shift marks a major advancement in the emergency treatment of type 1 allergic reactions, including anaphylaxis, by broadening access to a needle-free option for the youngest at-risk populations who were previously excluded by age restrictions. Prior to this update, pediatric patients were required to be at least 4 years of age in addition to weighing between 33 and 66 pounds to receive the 1 mg dose.¹

“We are very pleased that based on clinical data presented to FDA for neffy, that the agency removed the age requirement in the indication. 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,” Richard Lowenthal, co-founder, president, and CEO of ARS Pharma, said in a news release. “Caregivers often face tremendous fear administering needle-based treatment options, but now, neffy can be used safely in our most vulnerable young patients (≥33 lbs. and <66 lbs.), without age restrictions. This gives families access to a needle-free option that is simple to use, easy to carry, and designed to help them act quickly with confidence during emergencies.”

For pharmacists, this approval emphasizes their critical role in counseling caregivers who often face significant anxiety regarding needle-based auto-injectors. Clinical data indicates that approximately one-quarter of patients requiring epinephrine are children in the 33-to 66-pound weight range, and roughly 25% of that group is under the age of 4 years.

Pharmacists are now positioned to offer these families a needle-free alternative that is simple to use and designed to help them act quickly with confidence during emergencies, addressing a long-standing unmet need where parents often delayed treatment due to fear of hurting their child with a needle or accidental self-injection.

Dosing and administration remain central to the pharmacist’s educational outreach, as neffy is available in 2 distinct strengths based strictly on patient weight. The 1 mg dose is indicated for patients weighing 15 kg to less than 30 kg (approximately 33 to <66 pounds), and the 2 mg dose is the recommended dosage for children and adults who weigh 30 kg (approximately 66 pounds) or more. The medication is a single-dose spray administered into 1 nostril only. Updated labeling now provides more flexible guidance for patients, explaining that even if a patient sniffs after dosing, the management of the event remains the same as without sniffing. If symptoms do not improve within 5 minutes, a second dose should be administered using a new device in the same nostril.^1,2

Pharmacists should also educate patients on the unique storage and portability features of the device. The FDA recommends that patients carry neffy in its original blister packaging or a dedicated carrying case to ensure its integrity. ARS Pharma currently offers these cases free of charge and plans to include 1 in every prescription carton beginning this summer. Furthermore, the product offers significant temperature flexibility compared to traditional injectors, and it can be used once thawed if accidentally frozen and can withstand high-temperature excursions up to 122°F.¹

Clinical evidence supports the reliability of this nasal delivery method, with studies in healthy adults showing that neffy delivers comparable levels of epinephrine into the bloodstream as traditional injectable products while effectively increasing blood pressure and heart rate.²

In pediatric trials, 100% of patients responded to a single dose within a median of 16 minutes. Despite this efficacy, pharmacists must reinforce the necessity of carrying 2 devices at all times, as anaphylaxis can be unpredictable and may require a second dose if symptoms continue or recur.³

"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,” Nicole Chase, MD, allergist/immunologist at St. Paul Allergy & Asthma, said in the news release.¹ “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.”

Addressing barriers to access is another key area where pharmacists can provide value. Approximately 40 million people in the US experience type 1 allergic reactions, yet historical data shows that only a small fraction consistently carry their prescribed auto-injectors due to concerns over bulk, needle safety, and device complexity. To support widespread adoption, savings programs are available where most commercially insured patients pay only $25 per prescription, and a patient assistance program exists for those who are uninsured or underinsured. By staying informed on these updates, pharmacists can help ensure that the most vulnerable patients have access to a life-saving treatment they feel confident using.^1-3

READ MORE: Allergy Resource Center

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REFERENCES

1. ARS Pharmaceuticals receives FDA approval to remove age requirement from neffy 1 mg (epinephrine nasal spray) label. News release. ARS Pharmaceuticals. 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. Massaro L. FDA Approves First Needle-Free Epinephrine Nasal Spray. Drug Topics. August 9, 2024. Accessed March 27, 2026. https://www.drugtopics.com/view/fda-approves-first-needle-free-epinephrine-nasal-spray

3. Gallagher A. FDA Approves neffy for Treatmet of Type 1 Allergic Reactions, Anaphylaxis. Drug Topics. March 6, 2025. Accessed March 27, 2026. https://www.drugtopics.com/view/fda-approves-neffy-for-the-treatmet-of-type-1-allergic-reactions-including-anaphylaxis