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Aquestive Therapeutics Announces FDA Acceptance of New Drug Application and PDUFA Date for Anaphylm™ for the Treatment of Severe Allergic Reactions
FDA assigns PDUFA target action date of January 31, 2026 WARREN, N.J., June 16, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST)
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"FDA assigns PDUFA target action date of January 31, 2026 WARREN, N.J., June 16, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for Anaphylm™ in the treatment of Type 1 allergic reactions, including anaphylaxis, and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2026. The FDA reiterated that it may decide to conduct an Advisory Committee meeting for the approval of Anaphylm. If approved by the FDA, Anaphylm would be the first and only orally delivered epinephrine option for the treatment of severe allergic reactions in the United States. “Anaphylm represents a breakthrough in anaphylaxis treatment, if approved by FDA, being the first and only device-free, orally delivered epinephrine medicine,” said Dan Barber, President and Chief Executive Officer of Aquestive. “We designed Anaphylm to fit seamlessly into the patient’s daily life. It’s thinner than a credit card and requires no special storage, so patients can keep it in their phone case, wallet, or pocket – Anaphylm can go everywhere you go, without the bulk of even the smallest FDA-approved device for this patient population.” “Our clinical data demonstrates Anaphylm’s ability to rapidly deliver epinephrine absorption orally,” Mr. Barber continued. “With the FDA’s acceptance of our NDA, we’re one step closer to getting this life-saving innovation in the hands of the patients and caregivers who need it most.” \"Anaphylaxis is an unpredictable, severe allergic reaction that can be life-threatening within minutes. While epinephrine remains the only FDA-approved first-line treatment, too many at-risk individuals don't carry it consistently or hesitate to use it when seconds count,\" said Dr. David Stukus, M.D., Professor of Clinical Pediatrics and Director of the Food Allergy Treatment Center at Nationwide Children’s Hospital and The Ohio State University College of Medicine. \"The reality is stark: epinephrine can only save lives if people have it available and feel confident using it immediately. This potential drug produ...