FDA Approves Neffy as First Nasal Spray for Allergic Reactions: Daily Dose

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On August 9, 2024, we reported on the US Food and Drug Administration (FDA) approval of neffy (epinephrine nasal spray; ARS Pharma) for emergency treatment of type 1 allergic reactions, including anaphylaxis, in adults and children who weight at least 66 pounds.

The approval

The intranasal application is the first alternative to epinephrine delivered via manual syringe, the reference-listed drug and historical basis for efficacy for all other epinephrine products.

The FDA's decision is based on 4 clinical studies that included 175 healthy adults who did not have anaphylaxis. The findings showed comparable epinephrine blood concentrations between neffy or approved epinephrine injection products. Further, analysis of these data showed that pharmacodynamic (PD) surrogate marker responses for efficacy in anaphylaxis (systolic blood pressure and heart rate) correlated well with pharmacokinetic (PK) exposures. In a study of children who weighed more than 66 pounds, epinephrine levels achieved with neffy were similar to those seen among adults.

Neffy is administered via single dose nasal spray into 1 nostril. If there is no improvement or symptoms worsen, a caregiver may give a second dose, using a new unit of the nasal spray, in the same nostril. The same repeat administration pattern is recommended with injectable epinephrine. The FDA advises that emergency medical assistance may still be required for close monitoring of an anaphylactic episode and if additional treatment is needed to stabilize the individual.

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