Aquestive Therapeutics Announces Pivotal Study for Anaphylm (epinephrine) Sublingual Film Successfully Meets Primary and Secondary Endpoints and Provides Clinical Development Update Following FDA Meeting - Seite 2

David Golden, M.D., a renowned expert on anaphylaxis and an allergy-immunology consultant at Sinai Hospital of Baltimore and Franklin Square Hospital in Baltimore, stated, “The data from the Anaphylm pivotal study build on the compelling data generated from the prior Anaphylm pilot studies. These latest study results show that the sublingual administration of epinephrine provides rapid and sustained levels of epinephrine similar to approved treatments. Anaphylm is a promising needle-free alternative to the current standard of care, allowing patients to easily carry and administer this life-saving medication.”

Topline Data from Pivotal Phase 3 Study in Adults
The two-part, Phase 3, single-center, open-label, randomized study was designed to compare the PK and pharmacodynamics (PD) of single and repeat doses of Anaphylm versus single and repeat doses of the epinephrine intra-muscular (IM) injection and epinephrine autoinjectors (EpiPen and Auvi-Q) in healthy adult subjects. The primary endpoint was to compare the PK of epinephrine following the single administration of Anaphylm to the single administration of Adrenalin (epinephrine IM injection) and autoinjectors in healthy adult subjects. The secondary endpoints included evaluating PK sustainability following repeat administration and the safety and tolerability following single and repeat administrations versus epinephrine IM injection and epinephrine autoinjectors.

The single dose part of the Phase 3 study was designed as a four-period, four-treatment, four-sequence, comparative PK study with 64 enrolled adult subjects. As outlined in the presentation posted to the Company’s website and filed with the SEC today, key findings from the single dosing part of the study included that Anaphylm:

• Achieved a geometric mean Cmax of 470 pg/mL bracketed by epinephrine autoinjectors AUVI-Q at 521 pg/mL and EpiPen at 469 pg/mL,
• Generated partial AUCs between (bracketed) autoinjectors and Adrenalin manual IM injection from 5 to 60 minutes
• Maintained a median Tmax of 12 minutes compared to 20 minutes for EpiPen, 30 minutes for AUVI-Q, and 50 minutes for Adrenalin,
• Produced a meaningful change from baseline pharmacodynamic measures of blood pressure and heart rate at the first tracked time point of 2 minutes, and
• Was consistently well tolerated with no SAEs.