Aquestive Resubmits NDA for Anaphylm Sublingual Epinephrine Film After CRL
核心洞察
Aquestive Therapeutics has resubmitted its New Drug Application to the FDA for Anaphylm (dibutepinephrine) sublingual film for Type I allergic reactions (搜索), including anaphylaxis (搜索).
The resubmission follows a January 30, 2026 Complete Response Letter requesting a human factors study on packaging and administration plus a confirmatory pharmacokinetic study.
Revised packaging cut median pouch-opening time from 17 seconds to 3 seconds, and no protocol-defined use errors occurred in the self-administration arm of the PK study.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) announced on Sept. 17, 2026 that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration for Anaphylm (dibutepinephrine) sublingual film for the treatment of Type I allergic reactions (搜索), including anaphylaxis (搜索). The Warren, New Jersey-based company said the resubmission is supported by positive topline human factors and pharmacokinetic (PK) study results announced in August 2026.
The FDA will determine the resubmission classification and establish the applicable review timeline following its initial review of the resubmission, the company said.
Response to a Complete Response Letter
Aquestive's original NDA for Anaphylm was submitted in March 2025. The FDA issued a Complete Response Letter (CRL) on January 30, 2026, which requested that the company complete a human factors study addressing packaging and administration, and a confirmatory PK study of Anaphylm. Following receipt of the CRL, Aquestive held a Type A meeting with the FDA to discuss its proposed approach to addressing the matters identified in the letter.
In response, the company completed a human factors study evaluating revised packaging that incorporated modifications to the pouch opening, instructions for use, and pouch and carton labeling. Aquestive also completed a confirmatory PK study in healthy volunteers using the revised packaging and revised instructions for use. That study evaluated self-administration and clinician administration of Anaphylm and included manual intramuscular epinephrine as a comparator. No protocol-defined use errors were observed in the self-administration arm of the PK study.
"This resubmission reflects the rigor of our response to the FDA's Complete Response Letter, and we believe it addresses the items identified by the FDA in the Complete Response Letter," said Daniel Barber, President and Chief Executive Officer of Aquestive Therapeutics. "The completed studies generated human factors, pharmacokinetic, and pharmacodynamic data supporting the revised packaging design and instructions for use, including reducing median pouch-opening time from 17 seconds to 3 seconds."
Barber added that the company is preparing for a "focused, allergist-first launch" if the product is approved.
Pharmacodynamic Data and Clinical Rationale
David B.K. Golden, M.D.C.M., lead author of the 2023 Anaphylaxis (搜索) Practice Parameter and a member of Aquestive's Scientific Advisory Board, framed the potential clinical value of a needle-free option in the context of speed of treatment.
"When a patient experiences an anaphylactic reaction, rapid access to and administration of epinephrine are critically important," Golden said. "A small, highly portable and needle-free treatment option has the potential to address important barriers associated with carrying and administering epinephrine."
Golden noted that Anaphylm has previously demonstrated a rapid onset together with robust increases in heart rate and blood pressure, and that these pharmacodynamic responses were comparable to or greater than those observed with auto-injectors and manual intramuscular epinephrine in clinical studies. "Taken together, these characteristics suggest that Anaphylm, if approved, could represent a meaningful advancement in the treatment of severe allergic reactions, including anaphylaxis (搜索)," he said.
Product Characteristics
Anaphylm (dibutepinephrine) sublingual film is a polymer matrix-based epinephrine prodrug investigational product. According to the company, the film is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact, requiring no water or swallowing for administration. Its primary packaging is thinner and smaller than an average credit card, can be carried in a pocket, and is designed to withstand weather excursions such as exposure to rain and/or sunlight.
The Anaphylm trade name for AQST-109 has been conditionally approved by the FDA, with final approval of the proprietary name conditioned on FDA approval of the product candidate.
Pipeline Context
Aquestive describes itself as the worldwide leader in delivering medications on oral film, operating both as a developer of proprietary products and as a Contract Development and Manufacturing Organization for licensees, with headquarters in New Jersey and U.S.-based manufacturing facilities in Indiana. The company is the exclusive manufacturer of four commercialized products marketed by its licensees across six continents using technologies such as PharmFilm.
Aquestive's AdrenaVerse platform contains a library of more than 20 epinephrine prodrugs enabling the pursuit of various potential allergy and dermatological indications. Beyond Anaphylm, the company is advancing AQST-108 (epinephrine) topical gel for various potential dermatological conditions.
In pre-market trading on NasdaqGM, Aquestive shares were up 3.73 percent to $5.0 following the announcement, according to RTTNews.
The company's forward-looking statements note several risks, including the possibility that the FDA may determine the resubmission does not constitute a complete response to the CRL, may classify the resubmission differently than anticipated, or may request additional information, analyses, human factors studies or clinical studies.