U.S. FDA approves first nasal spray to treat dangerous allergic reactions

FDA approves Neffy nasal spray as needle-free alternative to EpiPen for severe allergic reactions, revolutionizing treatment.

U.S. health officials on Friday, August 9, 2024, approved a nasal spray to treat severe allergic reactions, the first needle-free alternative to shots like EpiPen.

The Food and Drug Administration (FDA) said it approved the spray from drugmaker ARS Pharmaceuticals Inc. as an emergency treatment for adults and older children experiencing life-threatening allergic reactions known as anaphylaxis.

Anaphylaxis occurs when the body's immune system develops a sudden, unexpected reaction to a foreign substance, such as food, insect stings or medications. Common symptoms include hives, swelling, itching, vomiting and difficulty breathing.

The device, marketed as Neffy, could upend treatment for the 33 million to 45 million Americans with severe allergies to food and other triggers. Anaphylaxis sends more than 30,000 people to emergency rooms and results in more than 2,000 hospitalizations and more than 230 deaths in the U.S. each year.

Of the 6 million prescriptions written for auto-injectors each year, more than 40% are never filled, Thomas Casale, an allergist at the University of South Florida, told an FDA advisory panel last year. Even when they are available to caregivers, many auto-injectors are used incorrectly, he said. “There’s a real unmet medical need for a large portion of the population,” he said.

Neffy is intended for people who weigh at least 66 pounds. It is given in a single dose sprayed into one nostril. A second dose can be given if the person’s symptoms don’t improve.

The new treatment could be life-changing for people with severe food allergies, said Kelly Cleary, a pediatrician and director with the Food Allergy Research & Education, a nonprofit advocacy group. “I have seen the look of worry or fear,” said Dr. Cleary, whose 11-year-old son has multiple food allergies. “I worry about what happens if someone hesitates.”