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Anticipating The FDA Decision of Anaphylm for Anaphylaxis, With David Golden, MD
As the January 31 PDUFA date approaches, Golden discusses that epinephrine sublingual film may deliver symptom relief as rapidly as autoinjectors, with added portability.
Ahead of the January 31, 2026, Prescription Drug User Fee Act (PDUFA) date for epinephrine sublingual film (Anaphylm) in the treatment of Type 1 allergic reactions, HCPLive spoke with investigator David Golden, MD, clinical associate professor of medicine at the Johns Hopkins University School of Medicine, about how this novel formulation compares with epinephrine autoinjectors and the clinical relevance of the oral allergy syndrome challenge that supported the New Drug Application (NDA).
According to Golden, the median time to symptom resolution was 15.1 minutes with sublingual epinephrine film, versus 74 minutes without.
“We like the fact that Anaphylm works very rapidly, as fast as the auto injector,” Golden said.
He continued, saying that many doctors in hospitals or clinics administer epinephrine by manual injection rather than an auto-injector. However, manual epinephrine injections do not work as quickly as epinephrine sublingual film or autoinjectors.
“That's one of the nice things that we can say about Anaphylm,” Golden added.
The NDA package included positive results from an oral allergy syndrome challenge, which found that allergic reaction symptoms resolved 2 minutes after epinephrine sublingual film administration.1 Epinephrine sublingual film, a polymer matrix-based epinephrine prodrug product candidate for anaphylaxis that weighs less than an ounce, showed promise in 11 independent clinical studies, encompassing approximately 967 administrations across 411 participants. At 10 minutes after epinephrine sublingual film administration, pediatric patients and adults had mean baseline-adjusted epinephrine concentrations over time of approximately 280 pg/mL and 330 pg/mL, respectively.2
“I’m a big fan of having choices, and I don't think any 1 [treatment] is the right thing for everyone,” Golden said. “I have patients who will want to and should probably just continue to have auto injector prescriptions, and some people don't exactly love nasal spray, so they may want to try a sublingual film. Some people will find it more portable to carry the sublingual film. Again, it actually addresses a number of the problems that keep people from carrying it and using it and has some advantages that will appeal to many people, but I think there's a place for every one of those products.”
References
Brooks A. FDA Accepts Epinephrine (Anaphylm) Sublingual Film NDA for Type 1 Allergic Reactions. HCPLive. Published on June 19, 2025. Accessed on January 22, 2026. https://www.hcplive.com/view/fda-accepts-epinephrine-anaphylm-sublingual-film-nda-type-1-allergic-reactions
Derman C. Aquestive’s Anaphylm for Severe Allergic Reactions Shows Promise in Children. HCPLive Published on April 1, 2025. Accessed January 22, 2026. https://www.hcplive.com/view/aquestive-s-anaphylm-for-severe-allergic-reactions-shows-promise-in-children
