Epinephrine is the medication form of adrenaline (a hormone produced by the human body) that aids in reversing the symptoms of an allergic reaction. As many members of the allergy community will be aware, an EpiPen® is commonly used to deliver this. It is an auto-injector device, used in an emergency to rapidly treat anaphylaxis, and consists of a pre-filled syringe fitted with a needle which contains a single dose of adrenaline for rapid injection into the muscle.
A three-part study called “EPIPHAST” is looking into the pharmacokinetics* and pharmacodynamics** of epinephrine delivered through an oral film (AQST-109) applied under the tongue (sublingual) as compared to intramuscular injection of epinephrine (with an EpiPen®). This film is about the size of a postage stamp and dissolves on contact. Water and swallowing are not required for AQST-109’s administration.
Phase 1 of the study, as presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting in February 2022, showed that sublingual administration of epinephrine can reach therapeutic concentrations in blood. During phase 2, “results were aligned with previous positive results reported for AQST-109, and the product candidate was well tolerated with no serious adverse events”. (Aquestive Therapeutics, Inc, 2022)
According to Allergy and Immunology specialist Dr. Oppenheimer, the product’s most appealing attribute is that it is small and portable, and the needleless delivery of AQST-109 “has the ability to significantly improve how patients and caregivers manage anaphylaxis and is expected to have a meaningful impact on the care of patients”.
Phase 3 of the study was expected to start in April 2022 and conclude by the end of June 2022.
*Pharmacokinetics – “characteristic interactions of a drug and the body in terms of its absorption, distribution, metabolism, and excretion”.
*Pharmacodynamics- “course of action, effect, and breakdown of drugs within the body”.
Above image courtesy of Aquestive.com, 2020.
Aquestive Therapeutics, Inc. (nd). Aquestive Therapeutics Reports Positive Topline Data from Part 2 of EPIPHAST Trial Evaluating AQST-109 Epinephrine Oral Film. https://aquestive.com/aquestive-therapeutics-reports-positive-topline-data-from-part-2-of-epiphast-trial-evaluating-aqst-109-epinephrine-oral-film/
Dictionary.com. (2022). Pharmacodynamics. https://www.dictionary.com/browse/pharmacodynamics
Food Allergy Canada. (2022). What is Epinephrine? https://foodallergycanada.ca/food-allergy-basics/preventing-and-treating-allergic-reactions/treating-reactions/what-is-epinephrine/
Healio. (2022). Sublingually administered epinephrine meets therapeutic thresholds. https://www.healio.com/news/allergy-asthma/20220302/sublingually-administered-epinephrine-meets-therapeutic-thresholds
Healio. (2022). Sublingually administered epinephrine continues to show promise.
Health Navigator. (2022). EpiPen®. https://www.healthnavigator.org.nz/medicines/e/epipen/#:~:text=An%20EpiPen%20is%20an%20auto,anaphylaxis%20%E2%80%93%20see%20signs%20of%20anaphylaxis.
Merriam-Webster Incorporated. (2022). Pharmacokinetics. https://www.merriam-webster.com/dictionary/pharmacodynamics#other-words
Allergy Today, May 2022