FDA Requests More Data on Needle-Free Epinephrine Nasal Spray, Delaying Approval

The FDA declined to approve Neffy, an epinephrine nasal spray for severe allergic reactions, pending additional clinical data.
The company developing Neffy, ARS Pharmaceuticals, expressed surprise and disappointment at the FDA's decision.
ARS plans to appeal the rejection and conduct another study, with hopes to resubmit an application in 2024.
Neffy aims to provide a needle-free alternative to epinephrine autoinjectors like EpiPen for treating anaphylaxis.
The FDA's rejection came despite an advisory committee previously recommending approval of Neffy.