FDA Rejects Needle-Free Epinephrine Nasal Spray neffy, Despite Advisory Panel Support

FDA rejected nasal spray alternative to EpiPen called neffy, requesting more study despite advisory committee recommendation.
CEO of ARS Pharma, maker of neffy, expressed surprise and plans to appeal but will also complete required trial.
Nasal spray would allow epinephrine administration without needles, training, or hesitation.
Patient advocates expressed frustration at FDA decision and need for needle-free epinephrine option.
Nasal spray could be more easily carried and used in schools, planes, and first-aid kits than injectable epinephrine.

usatoday.com

Relevant topic timeline:

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.