FDA approves first nasal spray to treat dangerous allergic reactions

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 said it has approved the spray from drug company 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 and 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 radically 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 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, Dr. 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 is a real unmet medical need for a large portion of the population,” said Casale, who serves on ARS Pharmaceuticals’ scientific advisory board.

Neffy is indicated for people who weigh at least 30 kg. It is administered as a single dose that is sprayed into one nostril. A second dose may be administered if the person’s symptoms do not improve.

The new treatment could be life-changing for people with severe food allergies, said Dr. Kelly Cleary, a pediatrician and director of Food Allergy Research & Education, a nonprofit advocacy group.

“I’ve seen expressions of concern or fear,” said Cleary, whose 11-year-old son has multiple food allergies. “I worry about what will happen if someone hesitates.”

For some children, the need for an emergency injection is as scary as the allergic reaction itself. Some parents have had to hold their children down to get shots, sometimes resulting in cuts that require stitches. About 3,500 caregivers a year are injured when they accidentally inject 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.

“Having to get an injection creates a whole different level of anxiety,” she said.

She said “we are very happy” about the FDA approval of the spray, which Zacky will begin carrying with him when it becomes available.

Epinephrine, first marketed in 1901, predates the FDA itself. Products such as the EpiPen auto-injector, 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 as well as injected epinephrine in increasing heart rate and blood pressure, which counteracts 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 in development to treat allergic reactions. Currently in development 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 CEO of San Diego-based ARS.

“We don’t want fear. With this product there are no needles and no pain,” he said. “It’s basically like spraying saline solution into your nose.”

ARS did not immediately disclose a list price but said it would make the spray available through certain discount programs for about $200 for a two-pack. Insurance plans have yet to decide whether to cover the product and at what price.

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