New Topline Data Released on Epinephrine Sublingual Film for Severe Allergies

Matthew Greenhawt, MD, MBA, MSc

Credit: Aquestive Therapeutics

An announcement was made by pharmaceutical company Aquestive Therapeutics, Inc., that topline pharmacokinetic (PK) data had been released regarding an epinephrine sublingual film (Anaphylm) for treatment of severe allergic reactions.¹

The drug, if approved by the US Food and Drug Administration (FDA), could become the first non-invasive and orally-administered epinephrine treatment for individuals with severe allergic reactions such as anaphylaxis. Anaphylaxis is a potentially fatal systemic hypersensitivity reaction which is known to impact up to 49 million people within the US.

“Experiencing and managing a severe allergic reaction can be unsettling and chaotic for patients and caregivers,” Matthew Greenhawt, MD, MBA, MSc, an allergist at Children’s Hospital Colorado and Aquestive Scientific Advisory Board member, said in a statement. “An orally administered product that can be rapidly and easily administered has the potential to be a game-changer for the allergy community.”

Around 52% of individuals who experience anaphylaxis never received a prescription for an epinephrine auto-injector prescription, commonly known as an EpiPen, and 60% did not have an available auto-injector. Admissions to hospitals due to reactions like anaphylaxis have increased by 500-700% over the course of the previous 10-15 years.

In this new announcement, the epinephrine sublingual film was noted as a potential solution to the well-known issues surrounding injectable epinephrine. In this new study, investigators utilized a single-dose, randomized crossover design and made comparisons between the PK and pharmacodynamics of the sublingual film.

Specifically, they compared pharmacodynamics and PK to the drug when it was self-administered, when it was administered by healthcare providers, and when patients received an Adrenalin manual intramuscular (IM) injection by providers. Some of the major PK parameters assessed by the research team included the maximum plasma concentration of epinephrine as well as the area under the curve (AUC) for exposure over time, evaluated using 36 healthy adults.

Prior research by Aquestive on this sublingual film has been reported by the HCPLive editorial team in March 2024.² This new data adds to the conclusions made following that period.

In their new findings, the investigators reported that no statistical difference was identified between self-administered and HCP-administered epinephrine sublingual film, adding that both versions achieved a 15-minute median time to maximum concentration. In contrast, the team noted that the Adrenalin IM injection led to a median of 50 minutes.¹

“Anaphylm encompasses many features important to patients and caregivers, including ease of carry, ease of administration, rapid delivery of epinephrine, and no needles,” Greenhawt said in a statement.

Around the third or fourth quarter of 2024, the investigators’ ongoing oral allergy syndrome challenge study is slated to conclude. A submission to the FDA of a New Drug Application (NDA) is planned around late Q4 2024 or early in 2025.

References

1. ^{Aquestive Therapeutics Reports Positive Topline Data For Anaphylm™ (Epinephrine) Sublingual Film From Self-Administration Study. Aquestive. July 25, 2024. https://investors.aquestive.com/news-releases/news-release-details/aquestive-therapeutics-reports-positive-topline-data-anaphylmtm. Date accessed: July 26, 2024.}
2. ^{Smith T. Positive Phase 3 Results Announced for Sublingual Epinephrine Treatment. HCPLive. March 18, 2024. https://www.hcplive.com/view/positive-phase-3-results-announced-sublingual-epinephrine-treatment. Date accessed: July 26, 2024.}