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Aquestive Therapeutics Announces FDA Clearance of Investigational New Drug Application (IND) for AQST-109 Epinephrine Oral Film
WARREN, N.J., Feb. 24, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to solve patients’
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"WARREN, N.J., Feb. 24, 2022 (GLOBE NEWSWIRE) -- 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 the opening of its Investigational New Drug Application (IND) from the U.S. Food and Drug Administration (FDA) for its drug candidate AQST-109 epinephrine oral film. “We are pleased that the FDA has cleared our IND to allow clinical investigation in the U.S. and look forward to continuing to advance the development program of this transformative therapeutic option for the emergency treatment of severe allergic reactions, including anaphylaxis,” said Keith Kendall, Chief Executive Officer of Aquestive. About AQST-109AQST-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. About AnaphylaxisAnaphylaxis is a potentially life-threatening systemic allergic reaction, with an estimated incidence of 50 to 112 episodes per 100,000 people per year. The frequency of hospital admissions for anaphylaxis has increased 500-700% in the last 10-15 years. The most common causes of reactions that can include anaphylaxis are medications, foods (such as peanuts), and venom from insect stings. Epinephrine injection is the current standard of treatment intended to reverse the potentially severe manifestation of anaphylaxis, which may include red rash, throat swelling, respiratory problems, gastrointestinal distress, and loss of consciousness. About Aquestive TherapeuticsAquestive Therapeutics is a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives. The Company has four approved and licensed products, and commercialized one internally-developed proprietary product to date, Sympazan® (clobazam) oral film. The Company a...