FDA Approves First Nasal Spray for Severe Allergic Reactions

The U.S. Food and Drug Administration (FDA) has approved neffy, an epinephrine nasal spray developed by ARS Pharmaceuticals, for the emergency treatment of severe allergic reactions, including anaphylaxis. This approval marks the first time a needle-free epinephrine product has been sanctioned for such use. Neffy is intended for adults and pediatric patients weighing at least 30 kilograms (66 pounds).

The FDA's decision is based on four studies involving 175 healthy adults, which demonstrated that neffy produces comparable blood concentrations of epinephrine to those achieved with traditional injectable products like EpiPen. Common side effects reported include throat irritation, tingling in the nose, headache, nasal discomfort, and jitteriness. Kelly Stone, MD, PhD, from the FDA’s Center for Drug Evaluation and Research, emphasized that the nasal spray addresses an unmet need and could reduce barriers to rapid treatment of anaphylaxis.