Aquestive to present subsequent analysis of data from Anaphylm study

Aquestive Therapeutics (AQST) announced that a subsequent analysis of the data from the pivotal study of its product candidate Anaphylm Sublingual Film demonstrating comparable PK and PD data regardless of variable placement or intraoral movement will be presented at the American College of Allergy Asthma and Immunology annual meeting, which is being held from October 24-28 in Boston, Massachusetts.”The poster, detailing a subsequent analysis of the data from the pivotal study of Anaphylm, being presented at ACAAI this year marks an important milestone in our development of Anaphylm, as it demonstrates the robustness and reliability of our sublingual film technology,” said Dan Barber, Aquestive’s CEO, “These findings show that our innovative PharmFilm delivery system maintains consistent pharmacokinetics and pharmacodynamics regardless of minor variations in placement, providing further evidence of Anaphylm’s potential to offer healthcare providers and patients a dependable alternative for the treatment of severe allergic reactions. Anaphylm has the potential to be the first and only FDA-approved no-needle, no-device, oral epinephrine product for treating severe allergic reactions, including anaphylaxis, if approved by the FDA.” The poster presentation will showcase a subsequent analysis of the previously disclosed pivotal study that successfully met primary and secondary endpoints, found at the link here. The subsequent analysis was conducted to evaluate the impact of intraoral film placement and movement on variability in PK and PD. Movement was noted in 12.5% of subjects. Results of the pivotal study demonstrated consistent drug delivery, with 87.5% of subjects showing no change in film location between 1.5 to 3 minutes after administration of Anaphylm. In cases where movement was noted, there were no significant differences between subjects with or without film movement in geometric mean maximum concentration, or Cmax, or median peak drug concentration, or Tmax. These findings support that the initial placement or subsequent movement of the sublingual film had no impact on epinephrine PK or PD, with all results comparable to epinephrine injection.