Aquestive Therapeutics, Inc. announced that the first patient has been dosed in its initial Phase 3 pivotal Pharmacokinetic (PK) clinical study of Anaphylm (epinephrine) Sublingual Film. Anaphylm is the Company?s orally administered epinephrine prodrug product candidate under development for the treatment of severe life-threatening allergic reactions, including anaphylaxis. The two-part, Phase 3, single-center, open-label, randomized study is designed to compare the PK and pharmacodynamics (PD) of single and repeat doses of Anaphylm versus single and repeat doses of the epinephrine IM injection and epinephrine autoinjectors (EpiPen and Auvi-Q) in healthy adult subjects.

The primary objective is to compare the PK of epinephrine following the single administration of Anaphylm to single administration of epinephrine IM injection in healthy adult subjects. The secondary objectives include evaluating PK sustainability following repeat administration and evaluating the safety and tolerability following single and repeat administrations versus epinephrine IM injection and epinephrine autoinjectors. Part A of the two-part Phase 3 is designed as a three-period, three-treatment, six sequence, comparative PK study and is expected to enroll up to 36 subjects.

Part A will assess both the PK performance and sustainability of Anaphylm 12mg with the bracketed comparison of an epinephrine autoinjector (EpiPen) and epinephrine manual IM injection. Part B is designed as a four-period, four-treatment, four-sequence, comparative PK study and is expected to enroll up to 64 subjects, inclusive of those who participated in Part A. Part B will assess the PK of a single dose of Anaphylm 12mg with the bracketed comparison of two autoinjectors (EpiPen and Auvi-Q) and the manual IM injection.