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The Food and Drug Administration (FDA) on Friday approved the first nasal spray treatment for serious allergic reactions including anaphylaxis.
ARS Pharmaceuticals’ neffy, which was approved for children and adults who weigh at least 66 pounds, is now the only needle-free alternative to EpiPens and other epinephrine injectors for treating potentially lethal allergic reactions. The nasal spray could eliminate barriers for people seeking treatment for anaphylaxis who are hesitant to inject themselves with a needle.
“Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections,” said Kelly Stone, an associate director at the FDA’s Center for Drug Evaluation and Research, in a press release. “The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis. As a result, neffy provides an important treatment option and addresses an unmet need.”
Neffy is a single-dose nasal spray that is administered into one nostril. A second dose can be administered if symptoms don’t approve following the first dose.
ARS Pharmaceuticals said that it expects neffy to be available in the United States within eight weeks. The company said it is committed to cap what most commercially insured patients pay for two single-doses of neffy at $25. Patients without health insurance will be able to get neffy for $199 via the digital pharmacy services BlinkRx and GoodRx GDRX-0.53%.
The FDA initially delayed neffy’s approval last September and requested more data. The agency said on Friday that it approved neffy based on four studies involving 175 adults. The studies showed “showed comparable epinephrine blood concentrations between neffy and approved epinephrine injection products.”
Anaphylaxis is a severe allergic reaction that can be caused by food, medications, and insect bites. About 500,000 emergency room visits a year are a result of anaphylaxis, according to ARS Pharmaceuticals.