A needle-free anaphylaxis treatment runs into an FDA roadblock

The FDA requested more data before advancing a nasal spray for anaphylaxis. The spray, neffy, would be a smaller and more easily administered rival to auto-injectors like the EpiPen.

Sep 20, 2023 - 20:00
A needle-free anaphylaxis treatment runs into an FDA roadblock

ARS Pharma had high hopes that the FDA on Tuesday would approve its flagship product, a needle-free treatment for adults and children with severe allergic reactions. But instead, the drugmaker was set back with the agency requesting an additional study.

Neffy, as the product is called, is a nasal spray that delivers the same drug, epinephrine, as the auto-injectors currently used to treat anaphylaxis.

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