On Tuesday, Aquestive Therapeutics Inc (NASDAQ: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 that their rescue medication will provide sufficient medicine as quickly as possible and without fail,” said Eleanor Garrow-Holding, President & CEO of Food Allergy & Anaphylaxis Connection Team.

The company’s remaining supportive studies, including the self-administration and oral allergy syndrome (OAS) challenge, are underway.

The self-administration study’s dosing is expected to conclude in the second quarter of 2024, and the OAS challenge study’s initial dosing is expected to occur in July 2024.

If approved by the FDA, Anaphylm (epinephrine) sublingual film has the potential to be the first and only non-invasive, orally delivered epinephrine for severe life-threatening allergic reactions, including anaphylaxis.

The company remains on track to complete Anaphylm supportive clinical studies and expects to request a pre-NDA meeting with the FDA in the third quarter of 2024.

Price Action: AQST shares are up 0.26% at $2.44 at the last check on Tuesday.

Photo by Evan Lorne via Shutterstock

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