Aquestive Therapeutics (NASDAQ:AQST) reported that the U.S. Food and Drug Administration has identified deficiencies in the new drug application for Anaphylm (dibutepinephrine), an oral sublingual film formulation for the emergency treatment of Type I allergic reactions, including anaphylaxis.
The company stated that these deficiencies currently preclude discussions on labeling, though the agency confirmed the review remains ongoing and no final decision has been made.
Aquestive noted that a Discipline Review Letter will not be issued at this time, but additional information requests are possible.
Any delays in communicating or resolving the identified deficiencies could impact the timeline and potentially delay approval prior to the PDUFA action date of January 31, 2026.
The Anaphylm development program encompasses 11 clinical studies involving approximately 967 administrations across 411 subjects, providing a substantial data package supporting the product's safety and efficacy profile.
Aquestive ended 2025 with approximately $120 million in cash, providing financial flexibility as it prepares for potential regulatory submissions in Canada, Europe, and the United Kingdom in 2026.
The company continues to engage with the FDA and expressed commitment to addressing the identified issues as expeditiously as possible to advance Anaphylm toward potential approval as a novel, needle-free alternative for anaphylaxis treatment.