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The US Food and Drug Administration (FDA) has approved the first nasal medicine to treat severe allergies.
On 9 August, US health officials approved the first nasal spray to treat allergic reactions from drugmaker ARS Pharmaceuticals Inc, an alternative to injectable allergy medications like EpiPen. The spray can only be administered to adults and children weighing at least 66 pounds.
The epinephrine spray is one of several needle-free devices being developed to treat millions of Americans with severe food allergies to food, as well as other triggers that lead to dangerous reactions, like anaphylaxis. Anaphylaxis typically occurs when the body’s immune system develops an immediate, unexpected response to a foreign substance, such as from food, insect stings, or medications. Those afflicted with anaphylaxis may experience hives, swelling, itching, and difficulty breathing.
“Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections,” Dr. Kelly Stone, associate director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research, explained in a press release. “The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis.”
The nasal spray will be marketed and sold under the name Neffy, with packaging that’s far more compact and easy to transport than most injectable epinephrine devices. It works as a single-dose nasal spray and should be administered into only one nostril, typically working within the next five minutes.
“Neffy delivers epinephrine, the same medication in epinephrine pens and autoinjectors, into your body to stop or slow down [or] counteract a life-threatening allergic reaction,” allergist Dr. Purvi Parikh explained to Popsugar.
It also will be the first allergy medicine accessible to the needle-averse. “Many who have severe allergies are afraid of needles or scared to inject themselves — this will help eliminate their fear,” she said.
Dr. Parikh added: “Also, other caregivers and Good Samaritans may be feel more comfortable using this rather than an injection in an emergency situation, so it can make the drug more quickly used and administered when it’s needed.”
With any medication, there are bound to be side effects – and Neffy isn’t an exception. According to the FDA, the epinephrine nasal spray bears similar side effects to injectable allergy medications like EpiPen, such as jitters and heart palpitations. However, side effects specific to Neffy include throat irritation, headaches, congestion, fatigue, runny noses, sneezing, vomiting, and nausea. Since the effects of epinephrine last up to 30 minutes, experts note that most of these side effects will subside during that time.
The nasal spray will officially hit the market in eight weeks. ARS Pharmaceuticals is reportedly planning to file for FDA approval for a lower-dose version of Neffy, which would work for children between 33 and 66 pounds.