The U.S. Food and Drug Administration (FDA) has approved a groundbreaking nasal spray designed to treat severe allergic reactions, marking the first needle-free alternative to traditional auto-injectors like EpiPen.
The FDA announced Friday that the nasal spray, developed by ARS Pharmaceuticals Inc. and branded as Neffy, is now an emergency treatment option for adults and older children experiencing life-threatening allergic reactions known as anaphylaxis. This condition occurs when the immune system reacts suddenly to allergens such as food, insect stings, or medications, leading to symptoms like hives, swelling, itching, vomiting, and difficulty breathing.
Neffy has the potential to transform the management of severe allergies, which affect between 33 million and 45 million Americans. Anaphylaxis annually sends over 30,000 individuals to emergency rooms, results in more than 2,000 hospitalizations, and contributes to over 230 deaths in the U.S.
Dr. Thomas Casale, an allergist at the University of South Florida, highlighted a significant issue with current treatments: over 40% of auto-injector prescriptions go unfilled, and those that are filled are often used incorrectly. “There’s a real unmet medical need for a large portion of the population,” Casale noted.
Neffy is designed for individuals weighing at least 66 pounds and is administered as a single spray into one nostril. A second dose can be given if symptoms persist. The new treatment offers a critical advantage for those with severe food allergies, according to Dr. Kelly Cleary, a pediatrician and director at Food Allergy Research & Education. She pointed out that for many, the fear of injecting a needle in an emergency situation is as daunting as the allergic reaction itself.
Parents of children with severe allergies have expressed relief at the approval. Priscilla Hernandez of Pasadena, California, shared that her son, Zacky, who has multiple food allergies, was deeply affected by a previous auto-injector experience at school. “We are over the moon” about Neffy’s approval, she said.
Unlike the EpiPen, which has been on the market since 1987, Neffy is based on modern technology that allows for easy nasal absorption of epinephrine. Clinical trials could not directly test the spray in emergency scenarios due to ethical constraints, but ARS Pharmaceuticals compared its effects to those of injected epinephrine using biological markers.
Neffy’s ease of use and needle-free administration are expected to be major benefits, especially for children. Richard Lowenthal, president and CEO of ARS, emphasized, “There’s no needle, there’s no pain with this product.”
The nasal spray will be available for approximately $200 per two-pack, though pricing and insurance coverage are still to be determined. Other needle-free epinephrine devices are also in development, including nasal sprays from Bryn Pharma and Nausus Pharma, a needle-free auto-injector from Crossject, and an epinephrine film from Aquestive Therapeutics.
