In a first, the Food and Drug Administration OKs needle-free epinephrine to treat anaphylaxis via nasal spray.

Published: September 11, 2024

A new nasal spray will give patients and families an alternative option for emergency treatment of severe allergic reactions. In August, the Food and Drug Administration (FDA) approved the first treatment for anaphylaxis by epinephrine nasal spray rather than an injection delivered through devices like the EpiPen.

Anaphylaxis, sometimes called anaphylactic shock, is a severe allergic reaction that can be life-threatening and is considered a medical emergency.

Signs of anaphylaxis include:

• A rash that feels like a relentless itch, hives or sudden swelling
• A feeling of constriction in your throat or chest, accompanied by wheezing or shortness of breath
• Upset stomach, nausea, or sudden bouts of vomiting
• A dramatic drop in blood pressure, leading to dizziness or even fainting

Epinephrine is a drug that can rapidly counteract the effects of anaphylaxis. Before this FDA approval, the lifesaving drug could be provided only through an injection, such as with an EpiPen. Neffy, the approved nasal spray version of the drug, is meant for children and adults who weigh more than 66 pounds.

“The potential to have a less-invasive and scary means of delivering a lifesaving drug is always a good thing,” said Mark A. Brockman Jr., M.D., a pediatrician with Norton Children’s Medical Group. “This will prevent hesitation in administration, especially by parents.”

The newly approved nasal spray option is expected to become available later this year.

Regardless of what form of epinephrine is used, Dr. Brockman recommends parents seek out additional medical attention after using the drug.

“Although the need for epinephrine in the home is rare, it does happen. After it is used, parents still need to seek medical attention in an emergency-room setting,” Dr. Brockman said. 

While allergies can start at any age, according to Dr. Brockman it is not typical for infants to develop severe allergies such as anaphylaxis. If a parent has questions or concerns on how to determine whether their child has severe allergies, they should contact their child’s pediatrician.

“Severity can change over time, and there are ways to desensitize people to certain allergens, thus lessening risks of anaphylaxis. We typically introduce foods, even high-allergen foods, around 6 months of age,” Dr. Brockman said. “Some allergens and the patient’s reactions to them can change over time, but it is important to follow closely with your pediatrician or allergist.”