- Reaffirms New Drug Application (NDA) first quarter 2025 submission guidance
- Confirms 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.
