AQST-109 Epinephrine Sublingual Film is the first and only orally delivered film using Aquestive's novel prodrug of epinephrine in clinical development that has the same target indication as that for epinephrine injection in the emergency treatment of Type 1 allergic reactions, including anaphylaxis.
Aquestive recognizes the need for an oral formulation of epinephrine and is leveraging its proprietary PharmFilm® technology to develop this treatment.
Anaphylaxis is a serious systemic hypersensitivity reaction with rapid onset and potentially fatal.
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.
In a nationwide patient survey by Wood, 52% of patients who had previously experienced anaphylaxis had never received an epinephrine auto-injector prescription and 60% of respondents did not have an epinephrine auto-injector currently available
Patients and caregivers using epinephrine auto-injectors often experience fear, anxiety, and needle phobia
"Speed matters in delivering systemic epinephrine during an anaphylaxis event. Any delay can result in severe bronchospasm, acute respiratory failure and/or cardiovascular collapse including less favorable outcomes including death."
Dr. David Bernstein, University of Cincinnati
"The PK profile of DESF shows an impressively rapid onset of action. The early Tmax and high Cmax fit the profile that is most desirable to stop anaphylaxis at an early stage and prevent progression to more severe reaction. The rapid achievement of high concentrations with DESF would seem ideal for early and effective treatment of anaphylaxis."
Dr. Golden , Sinai Hospital, Baltimore
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