Aquestive Therapeutics Announces FDA Confirmed 505(b)(2) Pathway for AQST-108 (Sublingual Film Formulation Delivering Systemic Epinephrine) for Anaphylaxis Treatment

• Pre-IND Meeting on AQST-108 Completed
• FDA Confirmed AQST-108 To Be Reviewed Under 505(b)(2)
• No Additional Clinical Studies Would Be Required Prior to Opening Proposed IND
• Pivotal Pharmacokinetic (PK) Clinical Trials Planned To Be Initiated Before Year End 2020

WARREN, N.J., Feb. 06, 2020 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that meet patients’ unmet needs and solve therapeutic problems, announced today that it had a constructive face-to-face pre-Investigational New Drug (IND) Application meeting with the U.S. Food and Drug Administration (FDA) for 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.

A pre-IND meeting provides an opportunity for an open communication between a drug sponsor and the FDA to discuss the sponsor’s IND development plan and to obtain the agency’s guidance for clinical studies for the sponsor’s new drug candidate.  The FDA has confirmed that the clinical development for AQST-108 will be reviewed under the 505(b)(2) pathway as proposed by Aquestive and that no additional studies would be necessary prior to opening the proposed IND Application.  The FDA indicated that there appears to be an unmet medical need among patients who resist the standard of care use of intramuscular injection in the treatment of anaphylaxis and that AQST-108 may potentially address some of those unmet needs.  Aquestive plans to move forward with opening an IND and initiating its pivotal pharmacokinetic (PK) clinical trials before the end of 2020.

“We are very pleased with the outcome of the pre-IND meeting with the FDA. We look forward to preparing the IND filing and commencing our pivotal 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 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.”