FDA Approves Neffy, First Nasal Spray for Severe Allergies

The U.S. Food and Drug Administration (FDA) has granted approval for the first nasal spray designed to treat severe allergies, marking a significant advancement in allergy management. On August 9, the FDA authorized the epinephrine nasal spray developed by ARS Pharmaceuticals Inc., providing an alternative to traditional injectable medications like the EpiPen. This new treatment is intended for adults and children who weigh at least 66 pounds and aims to address the urgent needs of those suffering from anaphylaxis, a severe allergic reaction that can lead to life-threatening symptoms. Dr. Kelly Stone, associate director of the FDA’s Division of Pulmonology, Allergy and Critical Care, emphasized the importance of this development, noting that many individuals, particularly children, often hesitate to seek treatment due to a fear of needles. The nasal spray, marketed as Neffy, is designed to be compact and easy to carry, allowing for rapid administration through a single dose in one nostril, typically taking effect within five minutes. This innovation is expected to alleviate the anxiety associated with injections for those with severe allergies. While Neffy offers a needle-free option, it is not without potential side effects. Similar to injectable epinephrine, users may experience jitters and heart palpitations. Specific side effects associated with Neffy include throat irritation, headaches, and gastrointestinal issues. Experts advise that most side effects will diminish within 30 minutes, aligning with the duration of epinephrine's effects. Overall, the introduction of Neffy represents a promising step forward in allergy treatment, potentially improving access and compliance for those at risk of severe allergic reactions.