In a new HCPLive interview, pediatric allergist Edwin H. Kim, MD, responded to the US Food and Drug Administration’s (FDA) recent decision not to approve what would have been the first non-injection, intranasal epinephrine treatment (neffy) for severe allergic reactions.¹

Kim works at University of North Carolina’s School of Medicine as an associate professor of pediatrics as well as director of the UNC Food Allergy Initiative research group.

The FDA’s response to ARS Pharmaceuticals’ new product was a Complete Response Letter (CRL) for neffy, a treatment developed to treat Type 1 allergic reactions such as anaphylaxis and a treatment that could have become a non-needle alternative to the EpiPen.

The move, Kim acknowledges, was surprising to some in the allergy field that had anticipated approval. This was especially true for some given that the FDA’s Pulmonary-Allergy Drug Advisory Committee (PADAC) had voted favorably in May 2023 to approve the product without further research into efficacy or safety.

“I will totally agree that this was definitely a surprising outcome,” he said. “And especially considering that the advisory committee that had met earlier this year wasn't unanimous, but it was definitely a majority that had felt comfortable with the data that was presented to them and had given sort of the thumbs up for approval. Of course you have to, at the end of the day, always have an ultimate purview over what they think is appropriate or not.”

Kim specifically was referring to the FDA’s CRL request that had contained a request for further pharmacokinetic/pharmacodynamic research, during which repeat doses of neffy could compare to an injection product with the team using allergen-induced allergic rhinitis conditions.

“I'm kind of reading between the lines here, but I don't get the sense that the FDA necessarily was just against a concept,” he said. “But if anything, it looked like they wanted some more data, some more reassurance on the actual medication doing what it's supposed to do. So I'm still holding out hope because I think, if anything, the last few months has made it very clear that there is a lot of interest in a non-injection form of emergency epinephrine.”

In a prior interview, Kim had discussed the potential value of the potential new treatment option for patients that may be hesitant about needles but have Type 1 reactions that can still be life-threatening. This time, he stressed that the idea is just as valuable.²

“You know, there is a level of trust that the medication will do what it needs to do at the time that you need it to happen,” he said. “And so if anything, this additional data probably speaks to that in my mind, a little bit. Just making sure in all circumstances, whether it's going to be a lot of nasal drainage or otherwise, that this medication can actually get in there and actually accomplish what it's supposed to accomplish.”

Kim added that if anything, he hopes the additional data that they end up coming away will give further credence to the actual modality itself, and then help to build that trust in providers and patients if it becomes broadly available.

“At least from my reading of the reply, it does look like they were looking for more data, not necessarily speaking to any data being faulty or incorrect, but more just more reassuring data,” he explained. “So my hope or my read of that is that if the company is able to conduct the studies that were requested and show the result, that even in those situations that the medication can be absorbed and get into the bloodstream.”

For further information on Kim’s response, view the full interview posted above.

The quotes used here were edited for the purposes of clarity.

References

1. ^{Smith T. FDA Declines to Approve of Epinephrine Alternative to EpiPen, Requests Further Study. HCPLive. September 20, 2023. Date accessed: September 26, 2023. https://www.hcplive.com/view/fda-declines-to-approve-of-epinephrine-alternative-to-epipen-requests-further-study.}
2. ^{Smith T. Edwin H. Kim, MD: Thoughts on Intranasal Epinephrine Spray as an Alternative to EpiPen. HCPLive. September 19, 2023. Date accessed: September 26, 2023. https://www.hcplive.com/view/edwin-kim-md-thoughts-intranasal-epinephrine-spray-as-alternative-to-epipen.}