FDA Approves Neffy, the First Needle-Free Nasal Epinephrine Spray for Children With Severe Allergies

For parents of children with severe food allergies, the moment of an allergic reaction has always been terrifying — not just because of the danger, but because the only available treatment required jabbing a panicked child with a needle. That era is now over.

The FDA approved Neffy, a needle-free nasal spray that delivers epinephrine through the nose, for children aged 4 and older weighing between 33 and 65 pounds. The device uses novel technology that temporarily loosens the junctions between nasal cells, allowing the medication to be rapidly absorbed into the bloodstream.

“That era is now over.”

This is the first major update to emergency epinephrine delivery in more than three decades. Since the EpiPen was introduced in the 1980s, injectable devices have been the only option for treating anaphylaxis — the severe, potentially fatal allergic reaction that can occur within minutes of exposure to allergens like peanuts, tree nuts, shellfish, and bee stings.

Food allergies affect approximately one in 13 children in the United States, and the prevalence has been rising steadily. Studies have shown that many caregivers and patients delay or avoid using injectable epinephrine due to needle phobia, complexity of the device, or fear of causing pain — delays that can prove fatal in severe cases.

Neffy eliminates these barriers entirely. The spray is administered with a single push into one nostril, requires no training to use, and causes no pain. Clinical trials demonstrated that it delivers therapeutically effective levels of epinephrine comparable to traditional autoinjectors.

Pediatric allergists have welcomed the approval as transformative. Many note that children as young as four can now carry their own emergency medication and even self-administer it, giving families and schools a simpler, less intimidating tool for managing life-threatening allergies. The approval marks a new chapter in allergy care, one where saving a child's life no longer requires a needle.