Brief: Aquestive Therapeutics Announces Completion Of FDA End-Of-Phase 2 Meeting For Aqst-109 (Epinephrine Sublingual Film)

Aquestive Therapeutics

22/12/2022 13:03

Dec 22 (Reuters) - Aquestive Therapeutics Inc  AQST.O :
    * AQUESTIVE THERAPEUTICS ANNOUNCES COMPLETION OF FDA
END-OF-PHASE
2 MEETING FOR AQST-109 (EPINEPHRINE SUBLINGUAL FILM)
    * FDA CONTINUES TO INDICATE THAT COMPANY CAN CONDUCT A
COMPARABILITY STUDY RATHER THAN EFFICACY STUDIES
    * FDA PROVIDES CLEAR GUIDANCE ON APPROVABILITY EXPECTATIONS
FOR
PHARMACOKINETIC PERFORMANCE, PATIENT ADMINISTRATION ATTRIBUTES
    * CONTINUES TO ANTICIPATE A POTENTIAL PRODUCT LAUNCH IN 2025
WITH
AN NDA SUBMISSION IN FIRST HALF OF 2024

Source text for Eikon:  ID:nGNX8v2n4v 
Further company coverage:  AQST.O 
 ((Reuters.Briefs@thomsonreuters.com))