By JONEL ARECIA AP Health Reporter
U.S. health officials on Friday approved a nasal spray to treat severe allergic reactions, providing the first needle-free alternative to injections like EpiPen.
The U.S. Food and Drug Administration said it has approved a spray made by drug company ARS Pharmaceuticals Inc. as an emergency treatment for adults and older children suffering from a life-threatening allergic reaction called anaphylaxis.
Anaphylaxis occurs when the body’s immune system suddenly and unexpectedly reacts to a foreign substance like a food, insect bite, medicine, etc. Common symptoms include hives, swelling, itching, vomiting and difficulty breathing.
The device, sold as Nephi, could transform treatment for the 33 million to 45 million Americans who suffer from severe allergies to foods and other triggers. Each year, anaphylaxis causes more than 30,000 emergency room visits, more than 2,000 hospitalizations and more than 230 deaths in the U.S.
Of the 6 million prescriptions for auto-injectors written each year, more than 40 percent go unfilled, Dr. Thomas Casal, an allergist at the University of South Florida, told an FDA advisory committee last year. Even when caregivers have access to auto-injectors, many are used incorrectly, he said.
“There is a real unmet health care need for a large portion of the population,” he said.
Nephi is intended for people weighing at least 66 pounds. It is administered as one spray into one nostril. If symptoms do not improve, a second dose can be given.
Dr. Kelly Cleary, a pediatrician and director of the nonprofit advocacy group Food Allergy Research and Education, said the new treatment could be life-changing for people with severe food allergies.
“I saw the look of concern and fear on their faces,” said Cleary, whose 11-year-old son has multiple food allergies. “I worry about what will happen if someone hesitates.”
The prospect of needing an emergency injection can be just as frightening for a child as the allergic reaction itself. Some parents have to restrain a violent child to administer the shot, which can result in cuts that require stitches. According to the ARS, about 3,500 parents accidentally inject themselves into their hands each year, injuring themselves.
Priscilla Hernandez of Pasadena, California, said her 12-year-old son, Zackie, who is allergic to foods including sesame, peanuts, tree nuts and avocados, had an allergic reaction at school about six years ago and was traumatized when a nurse treated him with an auto-injector.
“Having to get an injection creates a whole other level of anxiety,” she says.
“We’re ecstatic” about the FDA’s approval of the spray, she said, and that Zacky plans to carry it with her as soon as it’s available.
Epinephrine was first sold in 1901, making it older than the FDA itself. Products such as the EpiPen auto-injector, approved in 1987, were authorized based on chemistry and manufacturing data and did not have to demonstrate safety and effectiveness.
For ethical and practical reasons, clinical trials on people who have experienced fatal reactions are difficult, so instead, ARS officials compared the effects of the nasal spray on biological markers with existing epinephrine treatments.
The results showed that Nephi was roughly as effective as epinephrine, injected to raise heart rate and blood pressure to quell violent reactions. The drug is combined with a patented agent that is easily absorbed through the nasal mucosa.
Other needleless epinephrine devices are also being developed to treat allergic reactions. Products currently in development include a nasal spray from Bryn Pharma of North Carolina and Nausus Pharma of Israel, a needleless auto-injector from France’s Crossject, and a sublingual epinephrine film from Aquestive Therapeutics of New Jersey.
The Nefi is designed to be portable and easy to use, especially for children, said Richard Lowenthal, president and CEO of San Diego-based ARS.
“We don’t want you to be scared. There are no needles, no pain,” he said. “It’s basically like squirting saline in your nose.”
Nephi will be sold in packs of two and is expected to cost about the same as a two-pack of auto-injectors, about $300 to $700. Lowenthal said he hopes insurers will help cover the cost by keeping patient copayments low.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science Education Media Group. The AP is solely responsible for all content.
