ARS Pharmaceuticals announced today that the US Food and Drug Administration has approved an update to the prescribing information for neffy® 1 mg, its needle-free epinephrine nasal spray. The change removes the previous minimum age requirement, allowing use in all patients—children and adults—who weigh at least 33 pounds, regardless of age.
Previously, pediatric patients had to meet both the weight threshold and be at least four years old. The update now opens access to younger children who meet the weight criteria, a group that includes a significant number of patients at risk for severe allergic reactions.
“This is a major advancement for families with small children who live with the constant worry of severe allergic reactions,” said Richard Lowenthal, co-founder, president, and CEO of ARS Pharma. He noted that approximately 25% of patients weighing between 33 and 66 pounds are under the age of four, meaning many previously fell outside the labeled indication.
The updated labeling also includes practical guidance aimed at improving real-world use. It clarifies that sniffing after administration does not change how the reaction should be managed, and that a second dose is not needed if symptoms improve within five minutes. In addition, neffy may still be used if it has been accidentally frozen and thawed, and it can tolerate temperature excursions up to 122°F—important considerations for families on the go.
To support readiness during emergencies, the label now recommends carrying neffy in its blister packaging or in a dedicated carrying case. ARS Pharma currently provides these cases free of charge and plans to include one with every prescription beginning this summer. Each case is designed to hold two devices, consistent with guidance that a second dose may be needed if symptoms persist or return.
The move addresses longstanding barriers associated with traditional auto-injectors. “Parents often delay treatment because they are afraid of hurting their child with a needle,” said Nicole Chase, MD, an allergy/immunology and pediatrics specialist. “Having a needle-free option available to anyone who meets the weight criteria is an important step forward.”
Despite epinephrine being the only FDA-approved treatment for anaphylaxis, studies show it remains underused. While an estimated 40 million Americans experience Type I allergic reactions, only about 20 million have been diagnosed and treated for severe forms, and just a fraction consistently carry and use their prescribed auto-injectors. Fear, complexity, and portability issues all contribute to delays in treatment.
neffy is currently available in two doses: 1 mg for patients weighing 33 up to 66 pounds, and 2 mg for those weighing 66 pounds or more. As with all epinephrine products, patients are advised to administer treatment immediately at the first sign of a severe allergic reaction and get emergency medical help for further treatment if needed after using neffy.
