FDA Approves First Needle-Free Treatment for Anaphylaxis

A groundbreaking advancement in the treatment of life-threatening allergic reactions has arrived. The Food and Drug Administration (FDA) has approved the first needle-free treatment for anaphylaxis, a condition that can cause a sudden and severe reaction throughout the body. This new option, called Neffy, is a nasal spray formulation of epinephrine, the same medication found in EpiPens.

Epinephrine, also known as adrenaline, is a chemical naturally produced by the body that plays a crucial role in the fight-or-flight response. When administered during an anaphylactic reaction, epinephrine rapidly relaxes the muscles of the airways, preventing spasms and opening up passageways needed for breathing. It also helps reverse a dangerous drop in blood pressure by constricting blood vessels.

“Today’s approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection,” stated Dr. Kelly Stone, associate director of the Division of Pulmonology, Allergy and Critical Care at the FDA’s Center for Drug Evaluation and Research. “The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis, providing an important treatment option and addressing an unmet need.”

Neffy is approved for adult and pediatric patients weighing at least 66 pounds (30 kilograms). It is a single-dose spray intended for administration into one nostril. Similar to EpiPens, a second dose can be administered if a person’s symptoms do not improve, using a separate Neffy spray bottle and applying it to the opposite nostril. However, the FDA emphasizes the importance of seeking emergency medical assistance for close monitoring and potential further treatment.

While Neffy offers a convenient and accessible option, it’s important to note that certain medical conditions, such as a history of nasal surgery, may affect how well the medication is absorbed through the nasal tissues. Individuals with such medical histories should consult with a healthcare provider before using Neffy.

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