FDA Approves Neffy: First Needle-Free Nasal Spray for Severe Allergic Reactions

On August 9, 2024, the U.S. Food and Drug Administration (FDA) approved Neffy, the first needle-free nasal spray for the emergency treatment of severe allergic reactions, including anaphylaxis, in adults and children weighing at least 66 pounds. Developed by ARS Pharmaceuticals, Neffy delivers epinephrine—a life-saving medication traditionally administered via injection—through a single-dose nasal spray. This approval introduces a user-friendly alternative to traditional epinephrine auto-injectors like EpiPen, potentially transforming the management of life-threatening allergic episodes.

Anaphylaxis is a severe, life-threatening allergic reaction that can occur within seconds or minutes of exposure to an allergen, such as certain foods, medications, or insect stings. Symptoms may include hives, swelling, difficulty breathing, and loss of consciousness. Prompt administration of epinephrine is critical to counteract these symptoms. Traditionally, epinephrine has been administered via injection using auto-injectors like EpiPen. However, needle phobia and the complexity of using auto-injectors can lead to delays in treatment.

ARS Pharmaceuticals developed Neffy to address the challenges associated with needle-based epinephrine administration. The nasal spray is designed to be user-friendly, potentially reducing hesitation in administering the medication during emergencies. Clinical studies involving 175 healthy adults demonstrated that Neffy achieves blood epinephrine levels comparable to those of injectable products, with similar increases in blood pressure and heart rate—critical effects in the treatment of anaphylaxis.

The FDA's approval of Neffy was based on these clinical findings, addressing an unmet need for a non-injectable epinephrine option. Following the approval, Neffy was expected to be available in the United States within eight weeks, priced at $199 for two doses. ARS Pharmaceuticals also offered a co-pay savings program, allowing some commercially insured patients to access the treatment at $25 per prescription.

In March 2025, the FDA expanded Neffy's approval to include pediatric patients weighing between 33 and 66 pounds. The newly approved dose for this patient group is 1 milligram, while the dose for patients above 66 pounds remains at 2 milligrams. This expansion is expected to increase prescriptions, particularly during the back-to-school period. Neffy 1 mg was anticipated to be available by the end of May 2025 in the U.S., priced similarly to the 2 mg version at $199 for two doses.

The introduction of a needle-free epinephrine delivery system has significant societal implications. It addresses common barriers to prompt anaphylaxis treatment, such as needle phobia and the complexity of using auto-injectors. By offering a more user-friendly option, Neffy has the potential to improve treatment accessibility and compliance, especially among children and their caregivers. Advocacy groups have expressed strong support for this development, highlighting its potential to be a "game changer" for the allergy community.

ARS Pharmaceuticals is a biopharmaceutical company dedicated to developing innovative treatments for severe allergic reactions. The company's stock (ticker: SPRY) experienced a significant increase of over 13% following the FDA's approval of Neffy, reflecting investor confidence in the product's market potential.

The approval of Neffy represents a significant advancement in anaphylaxis treatment, offering a needle-free alternative to traditional epinephrine administration. This innovation has the potential to transform emergency allergy care by providing a user-friendly option that may improve patient outcomes and quality of life for those at risk of severe allergic reactions.