U.S. health officials on Friday approved a nasal spray to treat severe allergic reactions, the first needle-free alternative to injections like EpiPen.
The Food and Drug Administration has approved ARS Pharmaceuticals Inc.’s spray as an emergency treatment for adults and older children suffering from life-threatening allergic reactions, also known as anaphylaxis.
Anaphylaxis occurs when the immune system develops a sudden and unexpected reaction to a foreign substance, such as food, insect stings, or medications. The most common symptoms are rash, swelling, itching, vomiting, and difficulty breathing.
The device, to be sold as Neffy, could transform treatment for 33 million to 45 million people in the United States with severe food allergies and other triggers. Every year, anaphylaxis sends more than 30,000 people to the emergency roomresulting in 2,000 hospitalizations and more than 230 deaths in the country.
In 2023, Dr. Thomas Casale, an allergist at the University of South Florida, testified before an FDA panel that of the 6 million auto-injectable prescriptions written each year, more than 40% are never filled. Even when they are available to caregivers, many are used incorrectly.
“There is 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 and is administered as a single dose sprayed into one nostril, and a second dose may be administered if symptoms do not improve.
According to Dr. Kelly Cleary, a pediatrician and director of Food Allergy Research & Education, a nonprofit group, the new treatment could be life-changing for those with severe food allergies.
“I’ve seen the look of concern or fear,” said Cleary, whose 11-year-old son has multiple food allergies. “I am worried about what might happen if someone doubts.”
Needing a shot in an emergency is as scary for some children as the allergic reaction itself. In some cases, parents have had to hold down kicking children so they could get the shots, sometimes causing cuts that require stitches. About 3,500 caregivers are injured each year when needles accidentally stick themselves in the hands, according to ARS.
Priscilla Hernandez of Pasadena, California, said her 12-year-old son, Zacky, who is allergic to sesame, peanuts, tree nuts, avocado and other foods, was traumatized when he had a reaction at school about six years ago and a nurse treated him with an auto-injector.
“Getting a shot creates a whole other level of anxiety,” she said. “We are thrilled” that the FDA has approved the spray, which Zacky will begin carrying with him as soon as it is available.
First marketed in 1901, epinephrine is older than the FDA itself. Products like EpiPen, the auto-injectable approved in 1987, were approved based on chemical and manufacturing data and were not required to prove safety and effectiveness.
Clinical trials involving people experiencing life-threatening reactions are difficult for ethical and pragmatic reasons. Instead, ARS officials compared the nasal spray’s effect on biological markers to existing epinephrine treatments.
The results showed that Neffy worked almost as well as injected epinephrine in increasing heart rate and blood pressure, which counteract severe reactions. The drug is combined with a patented agent that allows it to be easily absorbed through nasal membranes.
Other needle-free options are being developed to treat allergic reactions. In the works are nasal sprays from North Carolina-based Bryn Pharma and Israel-based Nausus Pharma; a needle-free autoinjector from France-based Crossject; and an epinephrine film administered under the tongue from New Jersey-based Aquestive Therapeutics.
Neffy is designed to be easy to carry and use, especially for children, said Richard Lowenthal, president and chief executive of San Diego-based ARS.
“We don’t want fear. There is no water, there is no pain with this product”he said. “It’s basically like spraying saline solution into your nose.”
ARS did not disclose the retail price, but said the spray will be available through some discount programs for about $200 for a two-pack. Insurers have yet to decide whether to cover the product and at what cost.
