U.S. health officials have approved a nasal spray to treat severe allergic reactions. This is the first needle-free alternative to injections like EpiPen.
The Food and Drug Administration (FDA) approved the spray, developed by 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 has a sudden, unexpected reaction to a foreign substance, like food, insect stings, or medications. Common symptoms include hives, swelling, itching, vomiting, and difficulty breathing.
The device, marketed as Neffy, could change 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, results in over 2,000 hospitalizations, and over 230 deaths in the U.S. each year.
Out of the 6 million auto-injector prescriptions written annually, over 40% are never filled, according to Dr. Thomas Casale, an allergist at the University of South Florida. Even when available, many auto-injectors are used incorrectly, he said.
“There’s a real unmet medical need for a large portion of the population,” Dr. Casale stated.
Neffy is intended for individuals weighing at least 66 pounds. It’s administered in a single dose sprayed into one nostril. A second dose can be given if symptoms don’t improve.
The new treatment could be life-changing for people with severe food allergies, said Dr. Kelly Cleary, a pediatrician and director of the Food Allergy Research & Education, a nonprofit advocacy group.
“I have seen the look of worry or fear,” said Cleary, whose 11-year-old son has multiple food allergies. “I worry about what happens if someone hesitates.”
Requiring an injection in an emergency is as scary for some children as the allergic reaction itself. Some parents have had to restrain thrashing children to inject them, sometimes causing cuts requiring stitches. About 3,500 caregivers are injured each year when they accidentally inject themselves in the hands, ARS said.
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.
“Having to do a shot creates this whole different level of anxiety,” she said.
She said, “we are over the moon” about the FDA’s approval of the spray, which Zacky will start carrying when it becomes available.
First marketed in 1901, epinephrine predates the FDA itself. Products like the EpiPen auto-injector, approved in 1987, were authorized based on chemistry and manufacturing data and didn’t need to prove safety and efficacy.
Clinical trials of people experiencing potentially deadly reactions are difficult for ethical and pragmatic reasons. Instead, ARS officials compared the effect of the nasal spray on biological markers to existing epinephrine treatments.
Results showed Neffy worked about as well as injected epinephrine in boosting heart rate and blood pressure, which counter severe reactions. The drug is combined with a patented agent that allows it to be easily absorbed through nasal membranes.
Other needle-free epinephrine devices are being developed to treat allergic reactions. In development are nasal sprays from Bryn Pharma, of North Carolina, and Nausus Pharma, of Israel; a needle-free auto-injector from Crossject of France; and an epinephrine film administered under the tongue from Aquestive Therapeutics, of New Jersey.
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’s no needle, there’s no pain with this product,” he said. “It’s basically like spraying saline into your nose.”
ARS didn’t immediately disclose a list price but said it would make the spray available through certain discount programs for about $200 per two-pack. Insurance plans still need to decide whether to cover the product and at what price.