By Chris Wack

Aquestive Therapeutics Inc. said it has received a written response from the Food and Drug Administration to its pre-investigational new drug meeting submission confirming that the development of AQST-109 for the treatment of anaphylaxis under the 505(b)(2) pathway is acceptable.

The pharmaceutical company said the FDA's written response indicates that, pending review, Aquestive has performed sufficient clinical and nonclinical activity to support the opening of an Investigational New Drug application for AQST-109.

The FDA confirmed its agreement that the 505(b)2 pathway is appropriate for the development of AQST-109 and AQST-109 has the potential to meet the regulatory criteria for Fast Track designation. Aquestive plans to file its IND for AQST-109 early in the first quarter 2022.

Aquestive also said Health Canada has provided clearance for its crossover study of AQST-109. Patient recruitment has begun and the company expects the first dosing to occur before the end of the year. The study is a randomized, open-label, three-part adaptive design, crossover study intended to compare the pharmacokinetics and pharmacodynamics of epinephrine following administration of AQST-109 and epinephrine administered as intramuscular injection in healthy adult subjects.

Aquestive shares were up 5%, to $5.34, in premarket trading.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

December 13, 2021 08:39 ET (13:39 GMT)

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