USA – The U.S. Food and Drug Administration (FDA) has approved the first-ever nasal spray treatment for severe allergic reactions, offering a needle-free alternative to traditional epinephrine injections like EpiPen.
The newly approved device, Neffy, developed by ARS Pharmaceuticals Inc., is designed to treat life-threatening allergic reactions known as anaphylaxis, providing a crucial option for adults and older children.
Anaphylaxis is a rapid-onset allergic reaction that can occur when the body’s immune system reacts strongly to substances such as certain foods, insect stings, or medications. Symptoms include hives, swelling, vomiting, and difficulty breathing, often requiring immediate intervention.
Annually, anaphylaxis results in over 30,000 emergency room visits, 2,000 hospitalizations, and more than 230 deaths in the United States.
Neffy’s introduction marks a shift in the management of severe allergies, especially for the estimated 33 million to 45 million Americans who face the risk of anaphylactic reactions.
Traditionally, treatment has involved the use of auto-injectors, which deliver epinephrine via a needle. However, these devices can be intimidating, particularly for children, leading to hesitation or improper use during emergencies.
Dr. Thomas Casale, an allergist at the University of South Florida, highlighted the gap in current treatment options, noting that more than 40% of the 6 million auto-injector prescriptions written each year are never filled.
He emphasized the need for easier and less frightening alternatives for patients, particularly children.
Neffy, designed for individuals weighing at least 66 pounds, is administered in a single spray into one nostril, with a second dose available if symptoms persist. Unlike traditional injections, Neffy offers a pain-free option that could alleviate the anxiety associated with needle-based treatments.
Dr. Kelly Cleary, a Pediatrician and Director with the Food Allergy Research & Education organization, described the approval of Neffy as potentially life-changing, especially for children who dread the prospect of injections during an allergic reaction.
The development of Neffy involved a unique approach to clinical testing. Given the ethical and practical challenges of testing on patients experiencing severe reactions, ARS Pharmaceuticals compared the spray’s effect on biological markers with those of existing epinephrine treatments.
The results showed that Neffy was as effective as injected epinephrine in raising heart rate and blood pressure, key indicators in countering severe allergic reactions.
In addition to Neffy, other needle-free epinephrine treatments are currently in development, including nasal sprays and auto-injectors from companies in North Carolina, Israel, France, and New Jersey.
Richard Lowenthal, President and CEO of San Diego-based ARS Pharmaceuticals, emphasized the importance of reducing fear and anxiety in treating severe allergic reactions.
“We don’t want fear. There’s no needle, there’s no pain with this product,” he said, comparing the experience of using Neffy to spraying saline into the nose.
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