The first nasal spray to treat side effects approved by the FDA

By JONEL ALECCIA AP Health Writer

US health officials on Friday approved a nasal spray to treat asthma, the first needle-free alternative to shots like the EpiPen.

The Food and Drug Administration says it has received the spray from drugmaker ARS Pharmaceuticals Inc. as emergency treatment for adults and older children with life-threatening reactions known as anaphylaxis.

Anaphylaxis occurs when the immune system produces a sudden, unexpected reaction to a foreign substance, such as food, insect bites or medications. Common symptoms include hives, swelling, itching, vomiting and difficulty breathing.

The device, marketed as Neffy, could improve treatment for the 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 US each year.

Of the 6 million prescriptions written for auto-injectors each year, more than 40% are never filled, Dr. Thomas Casale, a pathologist at the University of South Florida, told an FDA advisory panel last year. Although available to carers, many car injectors are misused, he said.

He said: “There is a real unmet medical need for a large part of the population.

Neffy is designed for people weighing 66 kg. It is given as one 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 eating disorders, said Dr. Kelly Cleary, pediatrician and director of Food Allergy Research & Education, a nonprofit advocacy group.

“I saw a look of concern or fear,” says Cleary, whose 11-year-old son has multiple food allergies. I worry about what happens if someone hesitates.

Lack of vaccination in an emergency is as frightening to some children as an allergic reaction. Some parents have had to stop beaten children from injecting them, sometimes causing cuts that require stitches. About 3,500 caregivers a year are injured when they accidentally touch their hands, ARS said.

Priscilla Hernandez, of Pasadena, California, said her 12-year-old son, Zacky, who is allergic to sesame, peanuts, tree nuts, avocados and other foods, had a tantrum when he was six years old at school. past with the nurse. he caught her with a car charger.

“Having to shoot creates this different level of anxiety,” he said.

He said, “we’re over the moon” about FDA approval of the spray, which Zacky will begin taking when it becomes available.

First marketed in 1901, epinephrine predates the FDA itself. Products like the EpiPen auto-injector, approved in 1987, were approved based on chemistry and manufacturing criteria and were not required to prove safety and efficacy.

Clinical trials of people with potentially lethal reactions are difficult for both ethical and pragmatic reasons. Instead, ARS officials compared the effect of the nasal spray on viral symptoms with the existing epinephrine treatment.

The results showed Neffy worked as well as injected epinephrine to increase heart rate and blood pressure, which prevents strong emotions. This medicine is combined with a proprietary agent that allows it to easily penetrate the nasal membrane.

Other needle-free epinephrine devices are being developed to treat allergic reactions. In the pipeline are nasal sprays from Bryn Pharma, North Carolina, and Nausus Pharma, of Israel; a self-contained needle-free injector from France’s Crossject; and sublingual epinephrine film from Aquestive Therapeutics, of New Jersey.

Neffy 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 fear. No needle, no pain with this product,” he said. It’s basically like spraying salt in your nose.

The Neffy will come in two packs and is expected to cost as much as two packs of auto injectors, around $300 to $700. Lowenthal said he hopes insurance companies will reimburse patients for lower co-pays.

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