David B.K. Golden, MD, of Johns Hopkins, discusses anaphylaxis counseling, the Anaphylm CRL, and why a new epinephrine guideline is still years away.
"When and how to use epinephrine is no different for these different forms," Golden told HCPLive.
The interview builds on HCPLive's recent feature examining the
Neffy has been on the market for months, but the anaphylaxis guidelines meant to guide its use still haven't caught up. HCPLive's feature digs into why that gap exists, what it means for clinicians prescribing needle-free epinephrine today, and when new guidance might finally arrive.
Read the full feature: https://www.hcplive.com/view/epinephrine-nasal-spray-neffy-anaphylaxis-guidelines
Golden explained that guidelines distinguish between strong and conditional recommendations, and only 1 statement in anaphylaxis care meets the strong-evidence bar: that epinephrine should be given first and fast. Everything else, including which epinephrine product to prescribe, falls under conditional recommendations that require shared decision-making rather than a default answer.
Asked about the Complete Response Letter (CRL) issued for dibutepinephrine (Anaphylm) sublingual film, Golden said the FDA's concerns centered on packaging and labeling rather than the product's mechanism or effectiveness. The CRL cited human factors deficiencies, including difficulty opening the pouch and incorrect film placement, without raising concerns about safety, efficacy, or manufacturing quality.2
As co-chair of the AAAAI/ACAAI Joint Task Force's 2023 anaphylaxis practice parameter update, Golden said a revision covering the expanding field of alternative delivery routes will require published, real-world effectiveness data that does not yet exist.3 He estimated a new update is 3 to 5 years out, since comprehensive guideline revisions typically arrive only every 5 to 10 years.
Golden also flagged persistent misconceptions he hears from patients, including the belief that antihistamines or steroids can serve as a wait-and-see substitute for epinephrine or that a reaction can be monitored before treating.
"The longer you wait to use it, the less it's going to work," Golden said. "That's a really dangerous thing to say: ‘I'll just wait and see. If I feel worse, then I'll use it later."
Golden closed by reframing the entire clinical conversation around 3 questions he says patients are really asking, whether they use those words or not: “Will it work? Yes, if you use it right away. Can I trust it? Yes... And number three, is it dangerous? No, epinephrine is not a dangerous drug. The only thing that's dangerous is not using it when you should."
For a deeper look at why formal guidance hasn't kept pace with the newer epinephrine options, see
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