FDA Declines Approval of First Needle-Free Epinephrine Nasal Spray Neffy, Cites Need for More Data

FDA declined to approve needle-free epinephrine nasal spray Neffy, requested more data from drugmaker ARS Pharmaceuticals
In May, FDA advisory committee recommended approval of Neffy
FDA issued Complete Response Letter requesting assessment of repeat doses compared to injection
ARS CEO said they were surprised by FDA's request and believe in Neffy data package
Neffy would be first needle-free nasal spray for severe allergic reactions
Studies show many don't consistently carry epinephrine injectors due to fear of needles
Nasal spray could give more options to manage severe reactions for 40 million with allergies

cnn.com

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9/20/2023

FDA Rejects Approval for Needle-Free Epinephrine Nasal Spray Neffy, Requests More Research

The Food and Drug Administration rejects ARS Pharmaceuticals' epinephrine nasal spray, Neffy, the first needle-free alternative to epinephrine autoinjectors, requesting additional data and clinical studies before potential approval.