The new epinephrine treatment was developed by ARS Pharmaceuticals, Inc., and it is intended for both adults and children experiencing severe allergic reactions, including anaphylaxis. The potential approval by the FDA would mark a major development in the field of allergy.

Kim is known for his work in the field at University of North Carolina’s School of Medicine, working as Associate Professor of Pediatrics. He is also the director of the UNC Food Allergy Initiative research group here.

“Epinephrine historically has been the emergency medicine for allergic reactions anaphylaxis,” he explained. “And so of course, for me studying food allergy, this is critical and what we do, and the only versions that have been available to date have all been injections. Typically an auto injector, people are familiar with the EpiPen brand, but there's also multiple different brands now.”

Kim added that all current brands of the auto-injector involve a small needle that injects the medicine, the process of which can be problematic.

“I've been thinking ahead of how I would describe this to patients, and I think the number 1 point that is important to keep in mind here is that the medicine itself is going to be the same,” Kim said. “So it is epinephrine, the same life-saving medicine we think of in these injectable options that we have now. What's different is how it's actually delivered to our body. I think that is probably one of the most critical things that we anticipate will work because it's epinephrine.”

Kim noted the ease at which this treatment could potentially be applied, and consequently its potential popularity.

“We're excited to see what the uptake of this will be,” he said. “Because we do know for food allergies as well as other allergic reactions, probably the number 1 reason that a reaction becomes severe, or even worse, is because there's a delay or not giving up an effort at all. So something like this, that hopefully is going to be more accessible, easier to use, and not have the fear of an injection attached to it, hopefully will increase the likelihood that it'd be used when it's needed.”

The FDA’s Pulmonary-Allergy Drug Advisory Committee (PADAC) recently voted in favor of ARS-1, basing its decision on a detailed review of available clinical trial data, which showed a favorable risk-benefit profile for efficacy and safety versus traditional injection.¹

Although the PADAC's recommendations are known to be advisory, the move still holds weight with regard to the organization’s evaluation of the pending New Drug Application (NDA) submitted by ARS Pharmaceuticals, Inc.

For more of Kim’s views on the upcoming FDA decision, view the full HCPLive interview segment above.

The quotes used in this article were edited for clarity.

References

1. ^{Smith T. FDA Committee Votes in Favor of Intranasal Epinephrine for Severe Allergic Reactions Including Anaphylaxis. HCPLive. May 12, 2023. https://www.hcplive.com/view/fda-committee-votes-favor-intranasal-epinephrine-severe-allergic-reactions-including-anaphylaxis. Date accessed: September 19, 2023.}