Aquestive Therapeutics, Inc. (AQST), a pharmaceutical company, announced Monday positive topline results from the final two arms of Part 3 of the EPIPHAST study for its AQST-109 epinephrine oral film.
AQST-109 is a polymer matrix-based epinephrine prodrug administered as a sublingual film that is applied under the tongue for the rapid delivery of epinephrine.
EPIPHAST was a randomized, open-label, three-part adaptive design, crossover study comparing the pharmacokinetics and pharmacodynamics of epinephrine delivered through the company's AQST-109 oral film compared to intramuscular injection of epinephrine.
The study was being conducted pursuant to clearance from Health Canada.
According to the company, the purpose of Part 3 was to continue to study the administration of the film under a variety of conditions to further characterize its pharmacokinetics, pharmacodynamics, and safety.
The final two arms were designed to assess the impact of administering the film sublingually two minutes after consuming a peanut butter sandwich, and swallowing the film whole immediately with water.
Dan Barber, Chief Executive Officer of Aquestive, said, "We are thrilled to conclude and share the data from Part 3 of the EPIPHAST study further demonstrating AQST-109's strong and differentiated pharmacokinetic performance under a variety of conditions which now includes dosing the sublingual film after eating a peanut butter sandwich and swallowing the film whole immediately with water. It is very promising that AQST-109 continues to perform well in challenging and less than ideal circumstances, further validating performance and real-world functionality."
Aquestive said EPIPHAST II, a crossover study, is now underway, comparing AQST-109 to epi 0.3mg IM injection (repeat dose) and AQST-109 to EpiPen 0.3mg (single dose).
This data, along with the data from the complete EPIPHAST study, will be the basis for the End-of-Phase 2 meeting with the FDA that the company plans to request in the fourth quarter 2022.
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