FDA Approves First Nasal Spray for Treatment of Anaphylaxis

发布时间： 2024-08-13 阅读：162次

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August 9, 2024 -- ARS Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those that are life-threatening (anaphylaxis), in adult and pediatric patients who weigh at least 30 kilograms (about 66 pounds). The approval represents the first significant innovation in the delivery of epinephrine in more than 35 years and is the first and only needle-free treatment option for patients and families living with severe allergic reactions.

“Today’s approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection. Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections,” said Kelly Stone, MD, PhD, Associate Director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research. “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’s approval is based on four studies in 175 healthy adults, without anaphylaxis. Results from these studies showed comparable epinephrine blood concentrations between neffy and approved epinephrine injection products. A study of neffy in children weighing more than 66 pounds showed that epinephrine concentrations in children were similar to adults who received neffy.