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Aquestive Therapeutics Announces Positive FDA Feedback and Reaffirms NDA Submission Guidance for Anaphylm™ (epinephrine) Sublingual Film
Reaffirms New Drug Application (NDA) first quarter 2025 submission guidanceConfirms no additional adult clinical trials are necessary prior to NDA submission
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"Reaffirms New Drug Application (NDA) first quarter 2025 submission guidanceConfirms no additional adult clinical trials are necessary prior to NDA submission Commenced pediatric trial in the U.S. and Canada WARREN, N.J., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies (“Aquestive,” the “Company” or “we”), today announced receipt of positive feedback from the U.S. Food and Drug Administration (FDA) prior to its planned NDA submission for Anaphylm™ (epinephrine) Sublingual Film. Anaphylm has the potential to be the first and only orally delivered epinephrine product for the treatment of severe allergic reactions, including anaphylaxis, if approved by the FDA. “We believe FDA alignment on the completeness of our adult development program for Anaphylm is a major milestone for the Company and the allergy community,” said Daniel Barber, President and Chief Executive Officer of Aquestive. “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. Currently, the estimated 33 million Americans with food allergies only have the option of carrying epinephrine medical devices. 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. This patient community deserves continued innovation that creates easy-to-carry, easy-to-administer alternatives to today’s approved medical devices.” In a written response, the FDA agreed with the Company’s planned NDA content and format for the submission, planned safety evaluation, and planned pediatric trial, which has commenced at both U.S. and Canadian sites. The FDA also provided further guidance on additional data views to be included in the planned NDA submission and continued to emphasize their focus on pharmacokinetic sustainability for a single dose. In addition, the FDA requested minor modifications to the Company’s pediatric trial protocol. We have incorporated these FDA requested changes in the final pediatric trial protocol and do not expect these changes to have any signific...