The FDA has approved a significant update to Neffy (epinephrine nasal spray), removing the minimum age requirement for the 1 mg formulation. Announced on March 27, 2026, the change means any patient — child or adult — who weighs at least 33 pounds can now use Neffy as a first-line emergency treatment for anaphylaxis, regardless of how old they are.
Previously, younger children were excluded even if they met the weight requirement. Under the prior label, pediatric patients had to be at least 4 years old in addition to weighing between 33 and 66 pounds to be eligible for the 1 mg dose. That age floor has now been eliminated entirely.
Why This Matters for Families
Approximately 25% of patients in the 33-to-66-pound weight range are under the age of four — a group that was previously outside the labeled indication despite facing real anaphylaxis risk. This update directly addresses that gap.
Fear of needles is one of the most documented barriers to timely epinephrine use. Parents often delay treatment because they are afraid of hurting their child with a needle, and having a needle-free option available to anyone who meets the weight criteria is an important step forward.
That delay has real consequences. Despite the clear link between early epinephrine use and better outcomes, research shows that approximately 40% of patients delay treatment. A needle-free option that parents are actually willing to use quickly is the practical solution that label change supports.
How Neffy Works and Who It’s For
Neffy is a single-dose epinephrine nasal spray administered into one nostril. Dosing is based strictly on weight:
- 1 mg dose — patients weighing 33 to under 66 lbs. (approximately 15 to under 30 kg), now with no minimum age
- 2 mg dose — patients weighing 66 lbs. or more (approximately 30 kg or more)
Clinical evidence supports 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. In pediatric trials, 100% of patients responded to a single dose within a median of 16 minutes.
Patients whose symptoms worsen or do not improve can receive a second dose in the same nostril at least five minutes after the first. Carrying two devices at all times is recommended, since anaphylaxis can be unpredictable.
Updated Label Guidance
The March 2026 FDA update also clarified several practical points that are useful for patients and caregivers:
- Sniffing is not required. Efficacy is not dependent on the patient sniffing after administration.
- Freezing does not ruin the device. The device remains viable even if it has been accidentally frozen and thawed.
- Heat tolerance. Temperature excursions up to 122°F are allowed.
- Storage. Updated labeling recommends carrying Neffy in its blister packaging or a dedicated carrying case. ARS Pharma currently provides these cases free of charge and plans to include one with every prescription beginning this summer.
Real-World Performance
Real-world data from a study of 545 patients demonstrate that a single dose of the nasal spray achieves an 89.2% symptom resolution rate, comparable to intramuscular autoinjectors at 88.9%. That equivalence, combined with the practical advantages of a nasal spray — no needle, no injection technique required, easier to carry — makes Neffy a meaningful option for families managing severe allergies.
What This Means for Our Patients
At NY Allergy & Sinus Centers, we work with patients and families managing serious allergic conditions every day. Neffy’s expanded label is a development worth knowing about, particularly for parents of young children with diagnosed food allergies or other anaphylaxis triggers.
If your child has been prescribed an epinephrine device and you’d like to discuss whether Neffy is appropriate for them, contact our office at (212) 686-6321 to schedule a consultation with one of our allergists.
This article is for informational purposes only and does not constitute medical advice. Always follow the guidance of your allergist or physician regarding emergency medication.