Needle-Free Relief: FDA Approves Nasal Spray for Allergies
Published: August 14th, 2024.
In a groundbreaking move, the U.S. Food and Drug Administration (FDA) has approved Neffy, the first-ever nasal spray designed to treat severe allergic reactions, including life-threatening anaphylaxis. Manufactured by ARS Pharmaceuticals, Neffy offers a needle-free alternative to traditional epinephrine treatments like the EpiPen. This approval marks a significant advancement in managing severe allergies, providing a less intimidating option for patients who may delay treatment due to a fear of injections.
Neffy is a nasal spray containing epinephrine, the same active ingredient found in EpiPens and other auto-injectors. Epinephrine is a critical, life-saving drug that works by reversing the symptoms of anaphylaxis—a rapid and severe allergic reaction that can be triggered by foods, medications, insect stings, and other allergens. Anaphylaxis can cause symptoms like hives, swelling, difficulty breathing, and even loss of consciousness. Without prompt treatment, it can be fatal.
The approval of Neffy is particularly important for the estimated 33 to 45 million Americans who suffer from severe allergies. Each year, anaphylaxis leads to more than 30,000 emergency room visits, over 2,000 hospitalizations, and more than 230 deaths in the United States alone. Traditionally, the only FDA-approved method for administering epinephrine during an anaphylactic episode has been through injection. However, many individuals, especially children, are afraid of needles, which can lead to dangerous delays in treatment.
Kelly Stone, associate director of the Division of Pulmonology, Allergy, and Critical Care at the FDA’s Center for Drug Evaluation and Research, emphasized the importance of this new option. "Anaphylaxis is life-threatening, and some people, particularly children, may delay or avoid treatment due to fear of injections," Stone stated. "The availability of epinephrine nasal spray may reduce barriers to rapid treatment, making Neffy an important new tool in allergy management."
Neffy is administered as a single-dose spray into one nostril. A second dose can be given if symptoms do not improve, similar to the protocol followed with injectable epinephrine. After administering Neffy, patients are advised to seek immediate medical attention, as the nasal spray is intended as a rescue treatment rather than a definitive solution.
Like all medications, Neffy comes with potential side effects. Commonly reported side effects include nasal and throat irritation, headaches, and jitteriness—symptoms largely attributed to the effects of epinephrine itself. Despite these side effects, the benefits of having a needle-free option for administering epinephrine far outweigh the risks for many patients.
ARS Pharmaceuticals has announced that Neffy will be available in the U.S. within eight weeks following the FDA's approval. The cost of Neffy is expected to be around $200 for two single-use sprays, with some commercially insured patients eligible for a co-pay as low as $25. Additionally, patient assistance programs will be available to help uninsured or underinsured individuals access the medication at no cost.
The FDA's approval of Neffy represents a significant shift in treating severe allergic reactions. The EpiPen has been the gold standard in emergency allergy care for years, but its reliance on needle injections has been a major drawback for many patients. With Neffy, those with severe allergies now have a more accessible and less daunting option.
Looking ahead, Neffy is not the only needle-free epinephrine treatment in development. Other companies are exploring alternative delivery methods, including additional nasal sprays, needle-free auto-injectors, and sublingual films. These innovations could further expand patient options and potentially save more lives.