Aquestive Therapeutics Receives Written Response To Pre-IND Submission For AQST-109 And Begins Recruitment For Epinephrine Film Pharmacokinetic And Safety Trial; FDA Confirms 505(b)(2) Pathway Is Acceptable

FDA confirms 505(b)(2) pathway is acceptable for the development of AQST-109
 
FDA indicates AQST-109 has the potential for Fast Track designation
Health Canada provides clearance to commence the adaptive

• FDA confirms 505(b)(2) pathway is acceptable for the development of AQST-109
   
• FDA indicates AQST-109 has the potential for Fast Track designation
• Health Canada provides clearance to commence the adaptive design crossover study
   

WARREN, N.J., Dec. 13, 2021 (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, today reported that it has received a written response from FDA to its pre-investigational new drug (pre-IND) meeting submission confirming that the development of AQST-109 for the treatment of anaphylaxis under the 505(b)(2) pathway is acceptable.

The FDA's written response to Aquestive indicates that, pending review, Aquestive has performed sufficient clinical and nonclinical activity to support the opening of an Investigational New Drug (IND) application for AQST-109. In addition, the FDA provided comments on both Aquestive's toxicology plan and clinical development plan. The FDA confirmed its agreement that (i) the 505(b)2 pathway is appropriate for the development of AQST-109 and (ii) 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.

In addition, Health Canada has provided clearance for Aquestive's crossover study, known as the EPIPHAST study, of AQST-109. Patient recruitment has begun and the Company expects the first dosing to occur before the end of the year. The EPIPHAST 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. This study will be used to determine the final product configuration that will be used to manufacture registration batches and conduct pivotal studies planned for the second half of 2022.

"We are pleased with the FDA's responses to our Pre-IND meeting request," said Keith Kendall, Chief Executive Officer of Aquestive. "We believe the FDA's responses confirm our development plan and we will move to file our IND and have AQST-109 designated Fast Track as soon as practical. At the same time, we are pleased to announce that enrollment has begun in our EPIPHAST study. These updates, along with our upcoming PDUFA target goal date of December 23, 2021 for Libervant™ (diazepam) Buccal Film, make this an exciting time for Aquestive."