On Friday, U.S. health officials approved a new nasal spray called Neffy for treating severe allergic reactions, marking a significant advancement as the first needle-free alternative to traditional epinephrine shots like the EpiPen.
The Food and Drug Administration (FDA) sanctioned this spray from ARS Pharmaceuticals Inc. as an emergency treatment for adults and older children facing life-threatening allergic reactions known as anaphylaxis. This approval could transform the management of severe allergies in millions of Americans.
Anaphylaxis is a serious, rapid-onset allergic reaction triggered by substances such as food, insect stings, or medications, resulting in symptoms like hives, swelling, itching, vomiting, and difficulty breathing.
This condition sends over 30,000 people to emergency rooms annually and causes more than 2,000 hospitalizations and over 230 deaths in the U.S. each year. The introduction of Neffy, which can be administered as a nasal spray, offers a promising new option for those affected.
FDA Approves Neffy Nasal Spray as First Needle-Free Alternative for Treating Severe Allergic Reactions
Currently, over 6 million auto-injector prescriptions are written each year, but more than 40% of these prescriptions are never filled, and incorrect usage remains a significant issue. Dr. Thomas Casale from the University of South Florida highlighted the substantial unmet medical need for an alternative treatment.
Neffy, designed for individuals weighing at least 66 pounds, delivers a single dose via one nostril and can be repeated if symptoms persist, addressing the limitations associated with auto-injectors.
Neffy’s approval is seen as a breakthrough for people with severe food allergies. Pediatrician Dr. Kelly Cleary and other advocates emphasize that this spray could alleviate the anxiety and distress often associated with emergency injections.
Stories from families, such as Priscilla Hernandez’s account of her son Zacky’s traumatic experience with auto-injectors, illustrate the profound impact this new treatment could have on reducing fear and making emergency management less stressful for children and caregivers.
The nasal spray has shown comparable effectiveness to injected epinephrine in clinical trials, boosting heart rate and blood pressure to counter severe allergic reactions. Neffy is designed for ease of use and portability, particularly for children, without the pain associated with needles.
Expected to be priced similarly to a two-pack of auto-injectors at around $300 to $700, Neffy is anticipated to be covered by insurance, offering a new, less intimidating option for emergency allergic reaction treatment.
