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Aquestive Therapeutics to Present New Findings on Anaphylm™ (Epinephrine Sublingual Film) at the 2025 AAAAI Annual Meeting
Data show Anaphylm maintains consistent stability and potency under extreme temperature and real-world conditions, including heat, freezing, and water
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"Data show Anaphylm maintains consistent stability and potency under extreme temperature and real-world conditions, including heat, freezing, and water submersionNew findings demonstrate dosing of Anaphylm results in consistent epinephrine absorption without impacting safety or pharmacodynamic (PD) parametersAnaphylm pharmacokinetic (PK) and PD are not impacted by oral swellingMedian symptom resolution time was 12 minutes compared to 74 minutes without treatment; mean angioedema symptom resolution time was within 5 minutes. WARREN, N.J., Feb. 12, 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 multiple presentations highlighting results from the investigational use of Anaphylm epinephrine sublingual film in the treatment of severe allergic reactions, including anaphylaxis, will be featured at the 2025 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting. The meeting will take place February 28 - March 3, 2025, in San Diego, CA. “These latest results reinforce the strength of our clinical data and the potential of our product candidate Anaphylm as a reliable, portable, and effective treatment for anaphylaxis,” said Daniel Barber, Chief Executive Officer of Aquestive. “Anaphylm was designed to offer patients a more accessible option for emergency epinephrine administration, without the need for an injection or device, if approved by the FDA. These data further demonstrate Anaphylm’s performance under real-world conditions in resolving angioedema symptoms.” In the Phase 2 open-label Oral Anaphylm Symptom Intervention Study (“OASIS”) study, adults with Oral Allergy Syndrome (n=36) received Anaphylm under different conditions, including single and repeat dosing with and without oral allergen challenge (OAC), alongside intramuscular (IM) epinephrine injection as a comparator. The study found that: Anaphylm matched or exceeded IM epinephrine in all key PK parameters.No significant differences in drug performance compared to IM epinephrine were observed, regardless of whether patients had an oral allergen challenge or not.Median symptom resolution time was 12 minutes compared to 74 minutes without...