- Expects to initiate its planned pharmacokinetic (PK) clinical trials before year end 2020
- This program will be reviewed under the 505(b)(2) regulatory approval pathway
- AQST-108 may address an unmet need in patients requiring rescue medication for anaphylaxis
WARREN, N.J., June 29, 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 it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for pharmacokinetic (PK) clinical trials of its drug candidate AQST-108, a “first of its kind” oral sublingual film formulation delivering systemic epinephrine that is in development for the treatment of anaphylaxis using Aquestive’s proprietary PharmFilm® technologies. The Company intends to initiate its planned PK trials before the year end 2020.
Aquestive plans to initiate its PK clinical trials of AQST-108 in a crossover study to compare the pharmacokinetics and pharmacodynamics of epinephrine administered as sublingual film to that of epinephrine administered as an injection. As proposed by Aquestive and confirmed by the FDA at the pre-IND meeting held in February 2020, the clinical development for AQST-108 will be reviewed under the 505(b)(2) regulatory approval pathway. The FDA acknowledged that there appears to be an unmet medical need among patients who resist the standard of care use of subcutaneous and intramuscular injection in the treatment of anaphylaxis. The Company believes that AQST-108 may potentially address some of those unmet needs.
“As we have committed, we have completed the filing of the IND for AQST-108, which is a significant milestone for this development program. We are on track to commence our PK study before year end,” said Keith J. Kendall, Chief Executive Officer of Aquestive. “Anaphylaxis is a serious condition that impacts a large patient population for which there is a significant unmet need. The only options currently available to patients require an injection and, if approved by the FDA, AQST-108 can potentially bring meaningful innovation and positive change for patients. We are focused on providing the first highly portable, easy-to-administer and anxiety-free sublingual film medication to treat this serious condition.”