The FDA Declines Approval For First Needle-Free Epinephrine Treatment

The agency explained it needs more information about the alternative intake, including a study of repeat doses and comparison to the current injection form.

In a surprising move, the FDA has rejected to approve a needle-free Epinephrine for treatment of severe allergic reactions.

Drug-maker ARS Pharmaceuticals created ‘Neffy’ which is Epinephrine in nasal spray form. The agency explained it needs more information about the alternative intake, including a study of repeat doses and comparison to the current injection form.

If approved, Neffy would be the first needle-free nasal spray Epinephrine treatment for people with severe allergic reactions.

ARS said it anticipates it will resubmit the necessary data the FDA is requesting early next year in hopes to get Neffy approved by the end of next year.