The First Nasal Treatment for Anaphylaxis: FDA APPROVED!

Mohamad-Ali Salloum, PharmD • August 17, 2024

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Anaphylaxis is a severe, life-threatening allergic reaction that can occur rapidly, requiring immediate medical intervention. Traditionally, epinephrine autoinjectors have been the standard of care for such emergencies. However, the recent approval by the U.S. Food and Drug Administration (FDA) of a novel nasal spray, named neffy, marks a significant milestone in the management of anaphylactic reactions

What is Neffy?


Neffy (epinephrine nasal spray) is the first of its kind for the emergency treatment of allergic reactions (Type I), including anaphylaxis, in adult and pediatric patients who weigh at least 30 kilograms (approximately 66 pounds). This approval is particularly noteworthy as it introduces the first non-injectable form of epinephrine, potentially reducing barriers to rapid treatment due to needle phobia

Why Neffy was approved?


The approval of Neffy was based on four studies involving 175 healthy adults, which demonstrated that the epinephrine concentrations in the blood following administration of Neffy were comparable to those achieved with approved epinephrine injection products. Additionally, Neffy showed similar increases in blood pressure and heart rate, which are critical effects of epinephrine in treating anaphylaxis.

How is it Administered?


Neffy is administered as a single dose nasal spray into one nostril and may be given a second dose if symptoms do not improve or worsen. It is important to note that certain nasal conditions, such as nasal polyps or a history of nasal surgery, may affect the absorption of Neffy. In such cases, patients are advised to consult with healthcare professionals regarding the use of injectable epinephrine products

Conclusion:


The introduction of neffy is a welcome addition to the arsenal of anaphylaxis treatments, offering a needle-free alternative that may encourage more timely administration of life-saving epinephrine. As with any new medical product, ongoing monitoring and real-world data will be essential to assess the long-term efficacy and safety of this innovative treatment option.


References :


-FDA Approves First Nasal Spray for Treatment of Anaphylaxis.


Link: https://www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis


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    ABOUT THE AUTHOR

    Mohamad-Ali Salloum, PharmD

    Mohamad Ali Salloum LinkedIn Profile

    Mohamad-Ali Salloum is a Pharmacist and science writer. He loves simplifying science to the general public and healthcare students through words and illustrations. When he's not working, you can usually find him in the gym, reading a book, or learning a new skill.

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