Aquestive Therapeutics AQST-109 on FDA Fast Track

Having the opportunity to have “an orally delivered epinephrine” could be a game changer. Recently Aquestive Therapeutics, Inc. (NASDAQ:AQST), announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AQST-109, “the first and only orally delivered epinephrine-based product candidate for the emergency treatment of allergic reactions, including anaphylaxis”. The FDA Fast Track process is “designed to facilitate the development and expedite the review of potential therapies that seek to treat serious conditions and fill unmet medical needs.”

Aquestive Therapeutics AQST-109 on FDA Fast Track

FDA and Aquestive Logos

KFA News Team
April 10th, 2022
WARREN, N.J.

Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and provide transformative products to improve their lives, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AQST-109, the first and only orally delivered epinephrine-based product candidate for the emergency treatment of allergic reactions, including anaphylaxis.

“We are focused on continuing to develop and, if approved, bringing this transformative product to patients and caregivers given its potential to significantly improve how they manage anaphylaxis,” said Keith Kendall, Chief Executive Officer of Aquestive. “Fast Track designation is an indication that the FDA recognizes that AQST-109, if approved, fulfills a significant unmet need. An epinephrine oral film like AQST-109 would provide patients with a rescue medication where they need it, when they need it, and in a form they prefer.”

Fast Track is an FDA process designed to facilitate the development and expedite the review of potential therapies that seek to treat serious conditions and fill unmet medical needs. Programs with Fast Track designation may benefit from early and frequent communication with the FDA, eligibility for FDA accelerated approval, and priority review if relevant criteria are met, in addition to a rolling submission of the marketing application.

Aquestive recently announced results from Part 1 of its EPIPHAST study, a randomized, open-label, three-part adaptive design, crossover study in healthy adult subjects comparing the pharmacokinetics and pharmacodynamics of epinephrine delivered via AQST-109 oral film compared to intramuscular injection of epinephrine.

The Company commenced Part 2 of the study, which compares AQST-109 to intramuscular injection of epinephrine 0.3mg, which is the dosage of epinephrine auto-injectors. Aquestive expects to report topline results for the full EPIPHAST study in the first half of 2022.

Aquestive opened an Investigational New Drug Application (IND) with the FDA in February 2022. The Company anticipates conducting an end of Phase 2 meeting with the FDA during the second half of 2022.

About AQST-109

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. The product is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is required for administration. The packaging for AQST-109 is thinner and smaller than an average credit card, can be carried in a pocket, and is designed to withstand weather excursions such as exposure to rain and/or sunlight.

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