Posted 9/21/2023, 12:05:00 AM

FDA Declines Approval of Needle-Free EpiPen Alternative, Citing Need for More Safety Data

FDA declined to approve Neffy, an epinephrine nasal spray for severe allergic reactions, pending more trial data.
Neffy would have provided a needle-free alternative to EpiPens for treating anaphylaxis.
FDA wanted more data on safety of repeated doses before approval.
Company ARS Pharmaceuticals expressed disappointment and aims to complete new trial quickly.
Questions remain about whether nasal spray would be as effective as injections.

cbsnews.com

Relevant topic timeline:

9/20/2023

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

The US Food and Drug Administration has not approved a needle-free epinephrine treatment for severe allergic reactions, requesting additional information about the nasal spray instead.

9/20/2023

FDA Rejects Approval for Neffy, Nasal Spray Alternative to EpiPen, Despite Advisory Committee Backing

The US Food and Drug Administration has delayed the approval of a needle-free alternative to the EpiPen called neffy, requesting more studies to be completed before granting approval.