| 2019-09-30 07:11:08|
AQST 07:11 09/30 09/30/19
Aquestive Therapeutics announces completion of Phase 1 trial for AQST-108
Aquestive Therapeutics announced the completion of its Phase 1 dose escalation proof-of-concept study in healthy subjects for AQST-108. AQST-108 is an oral sublingual film formulation delivering systemic epinephrine that is in development for the treatment of anaphylaxis using Aquestive's proprietary PharmFilm technologies. Importantly, the data demonstrated that AQST-108: achieved similar ranges of mean values of maximum concentration and time to reach maximum concentration to that reported for injectables EpiPen and Auvi-Q; provided a greater total exposure than that reported for EpiPen and Auvi-Q; had less interpatient variability when compared to degree of variation data reported for EpiPen and Auvi-Q ; was well tolerated, with no study participants discontinuing participation due to an adverse event. Based on the results of this proof-of-concept study, Aquestive is in the process of scheduling a pre-IND meeting with the U.S. FDA.