U.S. health authorities on Friday approved a nasal spray to treat severe allergic reactions, the first needle-free alternative to injections like the EpiPen.
The Food and Drug Administration said it approved drugmaker ARS Pharmaceuticals Inc.’s spray as an emergency treatment for adults and older children suffering from potentially fatal 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 medication. Common symptoms include hives, swelling, itching, vomiting and difficulty breathing.
The device, marketed as Neffy, could harm treatment for 33 to 45 million Americans with severe food allergies 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.
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Of the 6 million prescriptions for autoinjectors each year, more than 40% are never filled, said 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 autoinjectors are used incorrectly, he said.
“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. It is administered as a single dose sprayed into one nostril. A second dose may be given if the person’s symptoms do not improve.
The new treatment could change the lives of 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 looks of concern or fear,” said Cleary, whose 11-year-old son has multiple food allergies. “I worry what will happen if someone hesitates.”
Requiring a shot in an emergency is as scary for some children as the allergic reaction itself. Some parents had to restrain struggling children to inject them, sometimes causing cuts that required stitches. About 3,500 caregivers a year are injured when they accidentally inject themselves into their hands, ARS said.
Priscilla Hernandez of Pasadena, Calif., 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. it with an autoinjector.
“Having to get a shot creates a whole different level of anxiety,” she said.
She said, “we are thrilled” with the FDA approval of the spray, which Zacky will begin selling when it becomes available.
First marketed in 1901, epinephrine predates the FDA itself. Products like the EpiPen autoinjector, approved in 1987, were authorized based on chemical and manufacturing data and were not required to prove safety and efficacy.
Clinical trials of people suffering potentially deadly reactions are difficult for ethical and pragmatic reasons. Instead, ARS officials compared the nasal spray’s effect on biological markers with existing epinephrine treatments.
The results showed that Neffy worked just as well as injecting epinephrine to increase heart rate and blood pressure, which counters severe reactions. The medicine is combined with a patented agent that allows it to be easily absorbed through the nasal membranes.
Other needle-free epinephrine devices are being developed to treat allergic reactions. In the pipeline are nasal sprays from Bryn Pharma of North Carolina and Nausus Pharma of Israel; a needle-free autoinjector from Crossject of France; and an epinephrine film administered under the tongue from New Jersey-based Aquestive Therapeutics.
Neffy was 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 needle, there is no pain with this product,” he said. “It’s basically like spraying saline solution up your nose.”
ARS did not immediately disclose the list price, but said it would make the spray available through certain discount programs for about $200 for a two-pack. Insurance plans must still decide whether they will cover the product and at what price.
This story originally appeared on Time.com read the full story
