- The FDA has granted Fast Track Designation to Aquestive Therapeutics Inc's (NASDAQ:AQST) AQST-109 for allergic reactions.
- AQST-109 is an orally delivered epinephrine-based product candidate for the emergency treatment of allergic reactions, including anaphylaxis.
- Aquestive recently announced results from Part 1 of its EPIPHAST study in healthy adult subjects comparing AQST-109 to intramuscular injection of epinephrine.
- The Company commenced Part 2 of the study, which compares AQST-109 to intramuscular injection of epinephrine 0.3mg, which is the dosage of epinephrine auto-injectors.
- Aquestive expects to report topline results for the full EPIPHAST study in 1H of 2022.
- Related: Aquestive Highlights Early Data From Allergy Treatment Candidate AQST-109 Study.
- Aquestive opened an Investigational New Drug Application (IND) with the FDA in February 2022. The Company anticipates conducting an end of Phase 2 meeting with the FDA during 2H of 2022.
- AQST-109 is a polymer matrix-based epinephrine prodrug administered as a sublingual film applied under the tongue for the rapid delivery of epinephrine.
- The product is similar to a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is required for administration.
- Price Action: AQST shares are up 4.60% at $2.73 during the market session on the last check Thursday.
