Impact of Nasal Epinephrine Spray for Patients with Severe Allergies, with Edwin H. Kim, MD

The US Food and Drug Administration (FDA) approved an epinephrine nasal spray formulated for emergency treatment of adults and children with severe allergic reactions like anaphylaxis. This treatment, the first non-injectable option for severe allergic reactions, is known as ‘neffy.’¹

The decision by the FDA is a significant milestone for patients who suffer from anaphylaxis who may be wary of needles. To address the drug’s significance in the allergy space, the HCPLive editorial team spoke with Edwin H. Kim, MD, associate professor of pediatrics at University of North Carolina’s School of Medicine.

“I do think that this has the potential to really dramatically change the landscape,” Kim said. “I think we have always known in the allergy field that epinephrine works. Epinephrine is able to stop allergic reactions, prevent anaphylaxis, and keep people safe. But we've also run into many situations where epinephrine is not administered, and for many reasons but one of the biggest ones is just fear and anxiety around the injection aspect.”

The FDA’s prior decision in September 2023 not to approve neffy for such patients was seen by many as a setback for those with severe allergies and a lack of alternatives to injectables.² Kim noted that the new approval changes circumstances for patients.

“We've had many stories where folks are thinking about holding on to the EpiPen, thinking ‘Should I use this? Should I not?’ and those kinds of delays sometimes can lead to bigger reactions,” Kim said. “So hopefully with a non-injection form of this, folks will be much more willing and open to not only use it but use it early on in a reaction to prevent these reactions from becoming more severe.”

Kim later spoke to what he viewed as important discussions for clinicians to have regarding the new nasal spray option.

“I think early on, it is definitely important to have an open discussion with our patients to explain what we know about the medication, but also what we may not know just yet,” Kim said. “Until we get that experience under our belt, I do think it's important for all of us to keep in mind that there is a weight limit to it at the moment. It is intended for patients that are 30 kilograms and over. And myself, being a pediatric allergist, a lot of my patients are under that so, at the moment, it's not approved for them.”

Kim also echoed the warning against use in the announcement of neffy’s approval for patients with certain nasal conditions, some of which included a history of nasal surgery or nasal polyps. Given the potential effects of such conditions, a consultation with a health care provider may be warranted.

For additional information, view the full interview posted above in the summary.

The quotes contained here were edited for the purposes of clarity. Kim reports personal fees from ALK, personal fees from Ukko Inc., personal fees from Kenota Health, personal fees from AllerGenis, personal fees from Genentech, personal fees from DBV Technologies, personal fees from Nutricia, personal fees from Novartis, personal fees from Revolo Biotherapeutics, grants from Food Allergy Research and Education (FARE), and grants from NIH-NIAID, outside the submitted work.

References

1. ^{Office of the Commissioner. FDA approves first nasal spray for treatment of anaphylaxis. U.S. Food and Drug Administration. August 9, 2024. Accessed August 9, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis.}
2. ^{Smith T. Edwin H. Kim, MD: Responding to FDA Decision Not to Approve ‘Neffy’ Treatment. HCPLive. September 26, 2023. https://www.hcplive.com/view/edwin-h-kim-md-responding-to-fda-decision-not-to-approve-neffy-treatment. Date accessed: August 12, 2024.}