The spray, marketed as Neffy, is the first needle-free alternative to shots like EpiPen.
U.S. health officials on Friday approved a nasal spray to treat severe allergic reactions, the first needle-free alternative to shots like EpiPen.
The device, marketed as Neffy, could upend 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.
“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.” 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 were not required to prove safety and efficacy.
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 auto-injector from Crossject of France; and an epinephrine film that is administered under the tongue from Aquestive Therapeutics, of New Jersey.
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