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On Tuesday, Aquestive Therapeutics Inc AQST released topline pharmacokinetic (PK) data from the temperature / pH study of its product candidate Anaphylm (epinephrine) Sublingual Film . Anaphylm is the company’s first and only orally administered epinephrine prodrug product candidate under development for severe life-threatening allergic reactions, including anaphylaxis. In March, Aquestive Therapeutics released topline clinical data from its Phase 3 PK study of Anaphylm, meeting all primary and secondary pharmacokinetic endpoints .
Pharmacokinetics is the movement of drugs into, through, and out of the body. The single-dose, five-period, randomized crossover study was designed to compare the PK and pharmacodynamics (PD) of Anaphylm just after consuming normal water, lemon water, and baking soda water. The primary PK parameters were the maximum amount of epinephrine measured in plasma (Cmax) and exposure, or the area under the curve (AUC), at various times after dosing in 30 healthy adult subjects.
Topline PK data from the study showed no statistically significant difference in PK results based on changes in temperature and pH. The most consumed beverages, such as soda, milk, coffee, and juice, have acidity between lemon water and normal water. While not statistically significant, alkaline substances like baking soda showed a somewhat higher absorption level than room-temperature water.
“Patients experiencing an allergic reaction must have confidence .
