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FDA Approves First Nasal Spray For Severe Allergic Reactions

A sign for the U.S. Food and Drug Administration is displayed outside their offices in Silver Spring, Md., Dec. 10, 2020. U.S. health regulators on Monday, July 29, 2024, approved a first-of-it

U.S. health officials have given their approval for the first nasal spray designed to treat severe allergic reactions, providing an alternative to injectable products like the EpiPen. This new nasal spray, developed by ARS Pharmaceuticals Inc., has been authorized by the Food and Drug Administration for use as an emergency treatment in adults and older children who are experiencing life-threatening allergic reactions known as anaphylaxis. It is specifically intended for individuals weighing at least 66 pounds.

Anaphylaxis is a serious condition that arises when the body's immune system reacts suddenly and severely to a foreign substance, such as food, insect stings, or medications. Symptoms of anaphylaxis can include hives, swelling, itching, vomiting, and difficulty breathing.

The newly approved nasal spray, to be marketed under the name Neffy, is part of a range of needle-free devices being developed to assist the estimated 33 to 45 million Americans who suffer from severe allergies to various triggers. Neffy is administered in a single dose sprayed into one nostril, offering a convenient and potentially life-saving treatment option for those in need.

This groundbreaking development in allergy treatment represents a significant advancement in providing accessible and effective care for individuals at risk of anaphylaxis. With the approval of Neffy, patients now have a non-invasive alternative to traditional injectable treatments, which could potentially improve outcomes and increase the likelihood of timely intervention during severe allergic reactions.

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