All about the first nasal spray approved by the US FDA to treat allergies
The US FDA has approved for the first time a nasal spray called Nefi containing epinephrine for the treatment of severe allergic reactions such as anaphylaxis.

In short
- Nefi is a nasal spray for anaphylaxis, offering an alternative to injections
- FDA accelerated approval of Nefi because studies showed it produced similar effects as injections
- People who have certain nose related problems or medical issues should consult a doctor before use
For the first time, a nasal spray containing epinephrine has been approved by the US Food and Drug Administration (FDA) for use in emergencies to treat severe allergic reactions.
This nasal spray called Nefi can help treat allergies such as anaphylaxis in both adults and children.
Nefi is given as a single spray into one nostril. If symptoms persist or get worse, a second dose may be needed.
Kelly Stone, associate director of the FDA’s Division of Pulmonology, Allergy and Critical Care, said anaphylaxis can be serious and life-threatening, and sometimes children hesitate or avoid treatment because of fear of injections.
“The introduction of epinephrine nasal spray may help overcome this barrier, making it easier to quickly treat anaphylaxis. Nefi provides an important new option for treatment and meets a critical need,” Stone said in an official statement.
Anaphylaxis is a dangerous condition that can be triggered by allergies such as certain foods, medications or insect stings. Epinephrine is the only life-saving treatment available for it, and it is traditionally given via injection.
The FDA granted expedited approval to Nefi, manufactured by ARS Pharmaceuticals.
Nefi’s approval came after four studies involving 175 healthy adults where researchers measured blood epinephrine levels after use of either Nefi or an approved epinephrine injection.
Studies have found that Nefi produces similar levels of epinephrine in the blood as injections, and has similar effects on blood pressure and heart rate, which are important for treating anaphylaxis.
A separate study done on children weighing more than 66 pounds showed that Nefi had similar effects as in adults.
Nefi is designed to be used as a single nasal spray, but like the injection, a second spray may be needed if symptoms do not improve or worsen.
After using Nefi, patients should seek emergency medical help to ensure that the allergic reaction can be properly monitored and treated if necessary.
Nefi also comes with some warnings. People with certain nasal problems, such as nasal polyps or a history of nasal surgery, may not absorb the medication as effectively and should talk to their doctor about using an epinephrine product in injectable form instead.
There are also precautions in place for people with certain medical conditions or those who are allergic to sulfites.
The most common side effects of Nefi include throat irritation, tingling in the nose, headache, nasal discomfort, nervousness, fatigue, tremors, runny nose, itching inside the nose, sneezing, stomach pain, gum pain, numbness in the mouth, nasal congestion, dizziness, nausea, and vomiting.