The Food and Drug Administration (FDA) has granted Fast Track designation to AQST-108 (Aquestive Therapeutics) for the treatment of allergic reactions (Type 1) including anaphylaxis.

AQST-108 is a sublingual film that delivers systemic epinephrine utilizing the Company’s proprietary technology. A pharmacokinetics (PK) trial comparing AQST-108 to subcutaneous and intramuscular injections of epinephrine is expected to begin in the third quarter of 2020.

“Fast Track designation confirms the unmet medical need for patients who are at risk for allergic reactions including anaphylaxis but reluctant and hesitant to use the standard of care, subcutaneous and intramuscular injections,” said Keith J. Kendall, CEO of Aquestive. “We believe that AQST-108, a highly portable, easy-to-administer sublingual film formulation delivering systemic epinephrine, satisfies this unmet medical need for this large underserved patient population.”

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The FDA’s Fast Track designation allows for expedited review of therapies that are meant to treat serious or life-threatening conditions. Generally, the designation is granted to drugs that are expected to have an impact on factors such as survival and daily functioning.

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Aquestive Therapeutics receives FDA Fast Track designation for AQST-108 (sublingual film formulation delivering systemic epinephrine) for treatment of allergic reactions including anaphylaxis. Accessed August 11, 2020.