The Food and Drug Administration (FDA) has granted Fast Track designation to AQST-109 for emergency treatment of allergic reactions, including anaphylaxis.
AQST-109 is a polymer matrix-based epinephrine prodrug administered as a sublingual film that is applied under the tongue for rapid delivery of epinephrine. The investigational drug is similar in size to a postage stamp and begins to dissolve on contact; no water or swallowing is required after administration.
The designation is supported by data from Part 1 of the EPIPHAST study, a randomized, open-label, 3-part adaptive design, crossover study comparing the pharmacokinetics and pharmacodynamics of AQST-109 to intramuscular epinephrine 0.5mg in healthy adults.
Findings demonstrated that AQST-109 delivered clinically meaningful blood concentrations of epinephrine sooner than that observed with the higher dose of epinephrine intramuscular injection. The median time to peak concentration for AQST-109 was 13.5 minutes. AQST-109 was found to be well tolerated with no serious adverse events reported.
The Company recently initiated Part 2 of the EPIPHAST study, which will compare AQST-109 to intramuscular epinephrine 0.3mg (the dosage of epinephrine autoinjectors).
“Fast Track designation is an indication that the FDA recognizes that AQST-109, if approved, fulfills a significant unmet need,” said Keith Kendall, Chief Executive Officer of Aquestive. “An epinephrine oral film like AQST-109 would provide patients with a rescue medication where they need it, when they need it, and in a form they prefer.”
- Aquestive Therapeutics receives FDA Fast Track designation for AQST-109 for emergency treatment of allergic reactions including anaphylaxis. News release. Aquestive Therapeutics, Inc. Accessed March 17, 2022. https://www.globenewswire.com/news-release/2022/03/17/2405174/0/en/Aquestive-Therapeutics-Receives-FDA-Fast-Track-Designation-for-AQST-109-for-Emergency-Treatment-of-Allergic-Reactions-Including-Anaphylaxis.html.
- Aquestive Therapeutics reports positive topline data from Part 1 of EPIPHAST trial evaluating AQST-109 epinephrine oral film. News release. Aquestive Therapeutics, Inc. February 25, 2022. Accessed March 17, 2022. https://aquestive.com/aquestive-therapeutics-reports-positive-topline-data-from-part-1-of-epiphast-trial-evaluating-aqst-109-epinephrine-oral-film/.
This article originally appeared on MPR