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Biopharmaceutical company Aquestive Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted the company's candidate drug AQST-108 fast-track qualification.
AQST-108 is an oral under-tongue membrane preparation that provides systemic epinephrine, a drug under development to treat type I. hypersensitivity.
type I hypersensitivity reaction, also known as an allergy reaction (allergy) or allergic reaction (anaphylaxis), is mainly mediated by specific IgE antibodies.
specific IgE antibodies against a strain factor are the main factors that trigger the type I. hypersensitivity reaction.
the content of normal human serum is very low, generally 0.1 to 0.4 sg/mL, the serum IGE antibody content of type I hypersensitive reaction is significantly increased, sometimes as high as 1000 sg/mL.
Aquestive was confirmed by the FDA in July 2020 to continue Phase I clinical trials of AQST-108 to compare pharmacodic dynamics and pharmacoetic differences between hypothyroid and intramuscular injections of epinephrine and AQST-108.
J. Kendall, chief executive of Aquestive, said: "Fast track eligibility confirms that the medical needs of hypersensitive responses have not yet been met.
We believe that AQST-108 is a highly portable and easy-to-operate product that releases epinephrine throughout the body to meet the medical needs of this large patient population."
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