First Time FDA Approves Nasal Epinephrine Spray for Anaphylaxis Treatment
In a groundbreaking development, ARS Pharmaceuticals has received FDA approval for Neffy, the first-ever nasal epinephrine spray for the emergency treatment of type I allergic reactions, including anaphylaxis, in adults and pediatric patients weighing at least 66 pounds.
This approval marks a significant milestone as the first needle-free epinephrine alternative, offering a new and innovative solution for those managing severe allergic reactions.
Previously Available Forms of Epinephrine
Before Neffy, the only available forms of epinephrine for emergency use were injectable devices like EpiPen, Auvi-Q, and Adrenaclick. These injectables have been the gold standard for over three decades but come with the challenge of needle use, which can be daunting for many.
The Advantages of Nasal epinephrine spray
Nasal epinephrine spray offers several distinct advantages over traditional epinephrine injectors:
First Needle-Free Epinephrine: As the first and only needle-free epinephrine product, Neffy eliminates the need for injections, addressing the fear and hesitation often associated with needle use.
Ease of Use and Portability: The nasal spray is simple to administer with just a quick spray into one nostril, reducing the potential for user error and making it more accessible in emergency situations. Its compact size also makes it easier to carry than traditional bulky injectors.
Safe and Effective: Clinical studies demonstrated that Neffy delivers comparable blood concentrations of epinephrine to those achieved by injectables. It also effectively increases blood pressure and heart rate, which are critical in treating anaphylaxis.
Broad Approval and Fast Track Designation: Neffy was granted Fast Track Designation by the FDA, underscoring its potential to meet an unmet medical need. It was approved based on results from four studies involving 175 healthy adults, showcasing its efficacy and safety.
Expanded Accessibility: With Neffy, epinephrine becomes more accessible in various settings like schools, restaurants, airplanes, and hotels, where accidental allergen exposure might occur. Its ease of use ensures that more people can confidently administer life-saving treatment when needed.
Who Can Recommend Neffy?
Neffy is suitable for both adults and children weighing at least 66 pounds who are at risk of severe allergic reactions. Healthcare professionals, including allergists, pediatricians, and general practitioners, can prescribe Neffy as an alternative to injectable epinephrine, particularly for those with needle phobia or difficulties with injections.
Is Neffy Available Over-the-Counter?
Neffy is not available over-the-counter and requires a prescription from a healthcare provider. This ensures patients receive proper guidance on usage and understand the importance of seeking emergency medical attention following administration.
Bottom Line
The approval of nasal epinephrine spray represents a significant advancement in the treatment of life-threatening allergies. By providing a needle-free alternative to traditional injectables, it addresses a critical unmet need and expands access to potentially life-saving treatment. As the first new delivery method for epinephrine in over 30 years, Neffy is poised to revolutionize how severe allergic reactions are managed, making it easier for patients and caregivers to act quickly and confidently during anaphylaxis.
