The U.S. Food and Drug Administration (FDA) has chosen not to grant approval for a nasal spray designed to address severe allergic reactions.
The U.S. Food and Drug Administration (FDA) has chosen not to grant approval for a nasal spray designed to address severe allergic reactions. The decision is based on the agency’s request for additional research regarding repeat doses of epinephrine, a critical drug for halting life-threatening anaphylactic reactions.
ARS Pharmaceuticals Inc., based in San Diego, was informed by the FDA that further study is needed to compare the effectiveness of their nasal spray device, named “neffy,” with traditional injections such as those administered via an EpiPen.
This decision comes after an FDA advisory committee had recommended the device’s approval approximately four months ago. While the FDA typically aligns with the committee’s recommendations, it is not obligated to do so.
ARS Pharmaceuticals’ President and CEO, Richard Lowenthal, announced the company’s intention to appeal the FDA’s decision. They plan to resubmit their application in early 2024.
The neffy nasal spray is among several needle-free solutions in development to address severe reactions to allergens like food, insect stings, and medications. If approved, this innovation could potentially revolutionize treatment for the estimated 33 to 45 million Americans with severe allergies.
Advocates for individuals with allergies expressed their frustration at the FDA’s call for further research. Sung Poblete, CEO of Food Allergy Research & Education, a nonprofit organization, stated, “Our community believed this innovation would finally benefit the more than 10% of Americans with life-threatening food allergies. Instead, the FDA will force us to wait even longer.”
The FDA’s decision reflects their commitment to thorough evaluation and ensuring the safety and efficacy of medical treatments. This additional research may provide crucial insights into the potential of neffy and its role in transforming the management of severe allergic reactions. The outcome of this ongoing investigation will be of keen interest to millions of individuals and families impacted by severe allergies across the United States.