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
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.
