Benzinga | Aug 10, 2020 07:42AM EDT

Aquestive Therapeutics Receives FDA Fast Track Designation For AQST-108 For Treatment Of Allergic Reactions Including Anaphylaxis

* Finalizing preparations for pharmacokinetic (PK) clinical trials of AQST-108

* First planned PK clinical trial expected to begin during the third quarter of 2020

WARREN, N.J., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients' unmet needs and solve therapeutic problems, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company's drug candidate AQST-108, a "first of its kind" oral sublingual film formulation delivering systemic epinephrine that is in development for the treatment of allergic reactions (Type 1), including anaphylaxis, using Aquestive's proprietary PharmFilm(r) technologies.



Fast Track is an FDA process designed to facilitate the development and expedite the review of therapies to treat serious conditions and fill unmet medical needs. Programs with Fast Track designation may benefit from early and frequent communication with the FDA, eligibility for FDA accelerated approval and priority review, if relevant criteria are met, in addition to a rolling submission of the marketing application.

Aquestive received confirmation from the FDA in July 2020 that the agency completed its safety review of its IND and concluded that the Company could proceed with the first planned PK clinical trials of AQST-108. As such, the Company expects to commence its first PK clinical trial utilizing a four-treatment crossover design to compare the pharmacokinetics and pharmacodynamics of AQST-108 to that of epinephrine administered as subcutaneous and intramuscular injections before the end of the third quarter of 2020.

"Fast Track designation confirms the unmet medical need for patients who are at risk for allergic reactions including anaphylaxis but reluctant and hesitant to use the standard of care, subcutaneous and intramuscular injections. We believe that AQST-108, a highly portable, easy-to-administer sublingual film formulation delivering systemic epinephrine, satisfies this unmet medical need for this large underserved patient population," said Keith J. Kendall, Chief Executive Officer of Aquestive. "Our first planned PK clinical trial will begin this quarter."