First-Ever Nasal Epinephrine Spray Approved by FDA for Anaphylaxis

In a pioneering move, ARS Pharmaceuticals has secured FDA approval for Neffy, marking the introduction of the first-ever nasal epinephrine spray designed for emergency treatment of severe allergic reactions, including anaphylaxis. This groundbreaking innovation is set to change the landscape of allergy management for both adults and children weighing at least 66 pounds.

A New Era in Epinephrine Delivery

For over thirty years, injectable devices such as EpiPen, Auvi-Q, and Adrenaclick have been the cornerstone of emergency anaphylaxis treatment. Despite their effectiveness, the need for needles has often been a barrier for many patients. Neffy breaks new ground by offering a needle-free alternative, making the administration of life-saving epinephrine simpler and less intimidating.

Why Neffy Stands Out

Neffy brings several notable benefits to the table:

Needle-Free Innovation: Neffy is the first epinephrine product to dispense with needles altogether. This eliminates the anxiety associated with injections, making emergency treatment more accessible for those with needle aversions.

Simplicity and Portability: The nasal spray is user-friendly, requiring only a single spray into the nostril. Its compact design contrasts sharply with the bulkier injectors, enhancing portability and convenience.

Proven Efficacy: Clinical trials reveal that Neffy achieves blood concentrations of epinephrine comparable to traditional injectors, effectively raising blood pressure and heart rate—essential factors in combating anaphylaxis.

Regulatory Support: Fast Track Designation by the FDA underscores Neffy’s potential to address an urgent medical need. Its approval was based on four studies involving 175 participants, validating its safety and effectiveness.

Enhanced Accessibility: Neffy’s ease of use ensures it can be effectively deployed in various settings, such as schools, restaurants, airplanes, and hotels, where allergic reactions may occur unexpectedly.

Who Can Benefit from Neffy?

Neffy is intended for both adults and children over 66 pounds who face the risk of severe allergic reactions. It offers a viable option for those struggling with needle phobia or difficulties with traditional epinephrine injectors. Healthcare providers, including allergists and pediatricians, are well-positioned to prescribe Neffy to suitable patients.

Prescription Requirement

Neffy is available only through a prescription, ensuring that patients receive comprehensive instructions on its use and understand the necessity of seeking medical care after administration.

In Summary

The FDA's approval of Neffy heralds a significant advancement in allergy treatment. As the first new method of delivering epinephrine in over three decades, it promises to revolutionize emergency care for anaphylaxis. By making life-saving treatment easier and more accessible, Neffy offers a crucial solution to a long-standing medical challenge.