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Aquestive Aquestive Therapeutics Successfully Demonstrates Repeatable and Predictable Oral Sublingual Film Administration of Epinephrine March 25 , 2021 • Provides in - depth scientific and clinical data in R & D event today at 9:00 am ET • Outlines data from two completed Phase 1 pharmacokinetic ( PK ) trials for AQST - 108 ( dipivefrin ) sublingual film • Articulates development strategy for second prodrug candidate , AQST - 109 sublingual film • Provides details on potential patent coverage to at least 2037 WARREN , N.J. , March 25 , 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 , will provide later this morning an in - depth overview of its systemic epinephrine drug delivery program combining its novel prodrug technology and its PharmFilmⓇ technology . At the R & D event , the management team and KOLs will share an extensive review of the science , clinical results , and development strategy associated with two prodrug candidates in development for the treatment of allergic reactions including anaphylaxis . Aquestive has submitted multiple U.S. and foreign patent applications that cover the technology and formulations for its two prodrug candidates , AQST - 108 and AQST - 109 . If granted , Aquestive anticipates patent protection for both drug candidates through at least 2037 . " Aquestive is , we believe , the first and only company that has successfully demonstrated a repeatable and predictable capability for orally administering a film for the delivery of systemic epinephrine as indicated by the results from the two completed Phase 1 PK trials with AQST - 108 that will be shared at today's R & D event , " remarked Dan Barber , Chief Operating Officer of Aquestive . " We have taken the learnings from the AQST - 108 studies regarding absorption and conversion and have applied them to the development of our second generation prodrug , AQST - 109 . We plan to commence a Phase 1 PK trial with AQST - 109 and anticipate a topline data readout in the second half of 2021. " " Today is an exciting day for the Aquestive team , " said Keith Kendall , President and Chief Executive Officer of Aquestive . “ Now that we have completed the submission of our initial patent applications , we are thrilled to provide our various stakeholders more insight into our scientific and clinical efforts to develop treatments for anaphylaxis . As we will discuss during our R & D event today , patients , caregivers , and healthcare providers remain highly interested in non - invasive routes of delivery for systemic epinephrine . Our surveys show that 80 % of patients surveyed are interested in PharmFilm replacing their current medical device and 96 % of patients surveyed believe that PharmFilm would be easier to administer during an emergency situation when compared to their current medical device . " AQST - 108 Sublingual Film Aquestive plans to outline in the R & D event today that its “ first of its kind ” oral sublingual film candidate delivering systemic epinephrine , AQST - 108 , is composed of the prodrug dipivefrin , which is contained within a unique polymeric matrix of Aquestive's PharmFilm technology . Dipivefrin is currently approved by the FDA for ophthalmic indications . Dipivefrin is enzymatically cleaved systemically into epinephrine after administration . Aquestive previously completed an initial PK trial ( Protocol 180299 ) . This study featured a single ascending dose design with between 6-12 healthy subjects completing each dosing level during Part I and Part II of the study . During the study , both PK and pharmacodynamic ( PD ) markers were measured . At the target dose level , the observed range for time to reach maximal concentration ( Tmax ) for AQST - 108 was 15-35 minutes , and the observed maximal concentration ( Cmax ) was 1487 pg / mL . In addition , this study indicated that AQST - 108 was rapidly converted to epinephrine with an observed epinephrine Tmax range of 20-60 minutes and an observed Cmax of 261 pg / mL . Aquestive recently completed its second Phase 1 PK trial in 28 healthy adult subjects , which featured a four - treatment crossover design comparing PK , safety and pharmacodynamics of AQST - 108 to that of epinephrine administered via both subcutaneous and intramuscular injections . In this study , the observed range for Tmax for AQST - 108 was 10-40 minutes and the observed Cmax for AQST - 108 was 1276 pg / mL . In addition , this study indicated that AQST - 108 was rapidly converted to epinephrine with an observed Tmax range of 11-106 minutes and an observed Cmax of 205 pg / mL . This was compared to an epinephrine Tmax range of 4-75 minutes and 8-68 minutes and Cmax of 475 pg / mL and 388 pg / mL for the intramuscular and subcutaneous injections , respectively . In addition , several pharmacodynamic markers were measured during the second Phase 1 PK study . AQST - 108 demonstrated changes from baseline in heart rate , systolic blood pressure , and diastolic blood pressure which are relevant in the context of anaphylaxis treatment and epinephrine's mechanism of action . For instance , for the area under the effect curve ( AUEC ) for systolic blood pressure , the median values for AQST - 108 and intramuscular injected epinephrine were 452 and 428 ( in hr * mm hg ) , respectively , indicating a comparable effect from both treatments on systolic blood pressure in healthy volunteers . A similar pattern was demonstrated for other pharmacodynamic measures as well . Aquestive plans on meeting with the FDA in the second half of 2021 to review these results and discuss next steps in the development of AQST - 108 . AQST - 109 Sublingual Film During today's R & D event , Aquestive will articulate its development strategy for a second epinephrine prodrug candidate , AQST - 109 sublingual film . AQST - 109 is a next generation prodrug of epinephrine that Aquestive intends to develop for sublingual treatment of allergic reactions including anaphylaxis . In vitro tests and preclinical studies indicate that AQST - 109 has the potential to absorb more extensively , convert more rapidly to systemic epinephrine , utilize less drug and provide a unique profile when compared to AQST - 108 . Aquestive anticipates conducting and completing a single ascending dose PK study in the second half of 2021. Based upon receiving favorable topline results from the study , Aquestive intends to request a pre - IND meeting with the FDA .