Anaphylm Sublingual Film for Anaphylaxis Receives Positive FDA Feedback

The US Food and Drug Administration (FDA) has provided positive feedback to Aquestive Therapeutics on Anaphylm (epinephrine) sublingual film for the treatment of severe allergic reactions, including anaphylaxis.¹

Announced by Aquestive on December 2, 2024, the FDA guidance reaffirmed the company’s plans for New Drug Application (NDA) submission in the first quarter of 2025, with no additional adult clinical trials required before application.

“We believe FDA alignment on the completeness of our adult development program for Anaphylm is a major milestone for [Aquestive Therapetuics] and the allergy community,” Daniel Barber, president and chief executive officer of Aquestive, announced in a statement. “We have commenced our single-dose pediatric trial in December 2024, and we believe we have a clear path to an NDA submission in the first quarter of 2025.”

A polymer matrix-based epinephrine prodrug product candidate, Anaphylm sublingual film begins to dissolve on contact and requires no water or swallowing for administration.² Aquestive compared the size to that of a US postage stamp with a weight of less than an ounce. Its packaging is thinner and smaller than an average credit card and is designed to withstand weather events.

Positive topline results from the Oral Allergy Syndrome (OAS) challenge study showed that Anaphylm sublingual film rapidly resolved symptoms of severe allergic reactions, beginning 2 minutes after administration, with 50% experiencing resolved symptoms by 5 minutes. Anaphylm achieved a comparable pharmacokinetic (PK) profile after allergen exposure to a non-allergen profile.

In the written response to Aquestive, the FDA confirmed the company’s planned NDA content and format for submission, safety evaluation, and the pediatric trial in children weighing ≥30 kg commenced at sites in the US and Canada.¹ Further FDA guidance focused on additional data views for the planned NDA submission, with an emphasis on pharmacokinetic sustainability for a single dose.

The agency also requested minor modifications to Aquestive’s pediatric trial, which the company has incorporated into the protocol. However, Aquestive does not believe these changes will significantly affect the planned timing of the pediatric trial.

Given the new route of administration and the trial data supporting this route, the FDA feedback indicated an advisory committee meeting may be required, according to Aquestive. Pending FDA approval, Anaphylm could become the first and only orally delivered epinephrine product for the treatment of severe allergic reactions, including anaphylaxis.

“Our engagement with the allergy community continues to inform us that bringing the first and only orally delivered epinephrine product for anaphylaxis to market can potentially be transformative for patients,” Barber added. “This patient community deserves continued innovation that creates easy-to-carry, easy-to-administer alternatives to today’s approved medical devices.”

References

1. _{Aquestive Therapeutics announces positive FDA feedback and reaffirms NDA submission guidance for ANAPHYLM (epinephrine) sublingual film. Aquestive Therapeutics. December 2, 2024. Accessed December 2, 2024. https://investors.aquestive.com/news-releases/news-release-details/aquestive-therapeutics-announces-positive-fda-feedback-and.}
2. _{Iapoce C. ANAPHYLM sublingual film achieves rapid resolution of allergen-related symptoms. HCP Live. October 24, 2024. Accessed December 2, 2024. https://www.hcplive.com/view/anaphylm-sublingual-film-achieves-rapid-resolution-of-allergen-related-symptoms.}