WARREN, N.J. - Aquestive Therapeutics , Inc. (NASDAQ: NASDAQ:AQST), a pharmaceutical company, announced positive results from its Phase 3 pharmacokinetic study of Anaphylm™, an orally administered epinephrine prodrug, for severe allergic reactions including anaphylaxis. The company also shared feedback from a recent Type C meeting with the U.S. Food and Drug Administration (FDA).
The study compared Anaphylm to epinephrine injections and autoinjectors such as EpiPen® and Auvi-Q®. Anaphylm achieved a median time to maximum concentration (Tmax) of 12 minutes, which is faster than the 20 minutes for EpiPen and 30 minutes for Auvi-Q. Exposure levels, measured as area under the curve (AUC), were comparable to autoinjectors for the first 30 minutes post-dosing.
Anaphylm was reported to be well-tolerated, with no serious adverse events (SAEs) noted. The repeat dosing part of the study maintained epinephrine plasma concentrations comparable to or greater than injection products at nearly all timepoints up to 2 hours.
Following the FDA's Type C meeting, Aquestive addressed concerns regarding product hold time, potential for emesis, and the impact of mouth conditions like angioedema. The FDA has recommended that Aquestive conduct a study assessing Anaphylm's performance after oral exposure to a known allergen, which is planned for the second quarter of 2024.
The company reaffirmed its goal to file a New Drug Application (NDA) with the FDA before the end of 2024, pending a positive pre-NDA meeting in the second half of the year.
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