A needle-free option for EpiPen users is in the works

A nasal spray medicine that would represent the first injection-free treatment for Americans with life-threatening allergies was rejected yesterday by the FDA, which said further research is needed before the treatment can be approved for use.

👃 How it works: The active ingredient in Neffy is epinephrine (aka adrenaline), which has been used in the US since 1901 to treat anaphylaxis, the most severe type of allergic reaction.

But all approved epinephrine treatments to date – including EpiPens and generic versions – require an injection via needle, which can cause some patients experiencing a life-threatening allergic reaction to hesitate in an emergency situation.

• Neffy instead opts for a simple nasal spray device, identical to those used in the drug overdose medication Narcan, to quickly deliver epinephrine to patients who have been exposed to an allergen like peanut butter, bee stings, or a bad meme (okay, maybe not the last one).

👀 Looking ahead… The FDA’s rejection came despite an advisory committee’s previous recommendation to approve Neffy without any additional trials or studies. FDA officials say they turned down the drug’s application due to a lack of data on its performance when the same patient is given repeat doses.

Drugmaker ARS Pharma plans to re-submit Neffy for FDA approval in 2024, after running an additional clinical trial studying repeat doses. More epinephrine nasal sprays are also in the pipeline, including an experimental treatment from Bryn Pharmaceuticals.