In a remarkable advancement for allergy treatment, the U.S. Food and Drug Administration has approved Neffy, the first nasal spray designed to treat severe allergic reactions, known as anaphylaxis. Developed by ARS Pharmaceuticals Inc., this innovative device offers a much-needed alternative to traditional injectable products like EpiPen. With an estimated 33 million to 45 million Americans suffering from severe allergies, this new treatment could significantly improve emergency response for those at risk.
Anaphylaxis can occur suddenly when the immune system reacts violently to substances such as food, insect stings, or medications. Symptoms can include hives, swelling, difficulty breathing, and even vomiting. Each year, more than 30,000 people in the U.S. visit emergency rooms due to anaphylaxis, resulting in over 2,000 hospitalizations and more than 230 deaths. The approval of Neffy could change the lives of many who face these dangerous allergic reactions.
Neffy is intended for individuals weighing at least 30 kilograms (66 pounds) and is administered as a single dose sprayed into one nostril. If symptoms persist, a second dose can be given. Dr. Thomas Casale, an allergist at the University of South Florida, noted that many auto-injectors are either not filled or used incorrectly, emphasizing the urgent need for alternatives. He stated that Neffy addresses a significant unmet medical need for a large portion of the population.
For families dealing with severe allergies, the emotional toll can be immense. Dr. Kelly Cleary, a pediatrician and director at Food Allergy Research & Education, shared her perspective as a parent of a child with multiple food allergies. She expressed relief at the approval, highlighting the anxiety that injections can cause for both children and parents during emergency situations. The nasal spray could alleviate this fear, making emergency treatment less daunting.
The approval of Neffy also resonates with families like that of Priscilla Hernandez from Pasadena, California. Her son, Zacky, has multiple food allergies and experienced trauma during a school incident when an auto-injector was used. Priscilla expressed her excitement about Neffy, stating, “We are over the moon” about the FDA's decision. The new spray offers a less intimidating option for children facing life-threatening allergic reactions.
Unlike traditional auto-injectors, which have been on the market for decades, Neffy was developed with modern technology that facilitates easy absorption through nasal membranes. Clinical trials compared Neffy’s effectiveness to existing epinephrine treatments by measuring biological markers related to anaphylaxis. The results indicated that Neffy works comparably to injected epinephrine, making it a viable emergency treatment option.
Other companies are also exploring needle-free alternatives for treating allergic reactions. Bryn Pharma from North Carolina and Nausus Pharma from Israel are developing their own nasal sprays, while Crossject of France is working on a needle-free auto-injector. Additionally, Aquestive Therapeutics from New Jersey is developing an epinephrine film that can be administered under the tongue. These advancements reflect a growing recognition of the need for safer, more accessible treatments for severe allergies.
Neffy will be packaged in sets of two and is expected to retail for approximately $300 to $700, similar to the cost of a two-pack of auto-injectors. ARS Pharmaceuticals hopes that insurance companies will provide coverage for the spray, allowing patients to access it with minimal out-of-pocket expenses. With the approval of Neffy, many individuals and families affected by severe allergies can look forward to a safer, more convenient method of managing life-threatening reactions.
