on tuesday, Aquestive Therapeutics, Inc. (Nasdaq:Aquaesty) has published top-line pharmacokinetic (PK) data from temperature/pH studies of its product candidate Anafila (epinephrine). Sublingual film.
Anafim is the Company’s first and only orally administered epinephrine prodrug candidate being developed for the treatment of severe, life-threatening allergic reactions, including anaphylaxis.
In March, Aquestive Therapeutics announced topline clinical data from its Phase 3 PK study of Anaphylm, meeting all primary and secondary endpoints. Pharmacokinetic endpoints.
Pharmacokinetics refers to the phenomenon of how a drug moves into, through, and out of the body.
A single-dose, five-period, randomized crossover study was designed to compare the PK and pharmacodynamics (PD) of anaphylaxis immediately following ingestion of regular water, lemon water, and baking soda water.
The primary PK parameters were the maximum amount of epinephrine (Cmax) and exposure, or area under the curve (AUC), measured in plasma at various time points after administration to 30 healthy adult subjects.
Topline PK data from this study showed no statistically significant differences in PK outcomes based on changes in temperature and pH.
Most commonly consumed beverages, such as soda, milk, coffee, and juice, have an acidity level somewhere between that of lemon water and plain water.
Although not statistically significant, alkaline substances like baking soda showed slightly higher absorption levels than room temperature water.
“Patients experiencing an allergic reaction need to be confident that their rescue medications will provide adequate relief as quickly as possible,” said Eleanor Garrow Holding, president and CEO of The Food Allergy & Anaphylaxis Connection Team.
The company’s remaining ancillary studies, including self-administration and oral allergy syndrome (OAS) challenge, are currently ongoing.
Dosing for the self-administered study is expected to finish in the second quarter of 2024, with the first dose of the OAS challenge study expected to occur in July 2024.
If approved by the FDA, it could become the first and only sublingual film to provide non-invasive, orally administered epinephrine for severe, life-threatening allergic reactions, including anaphylaxis.
The company plans to complete clinical trials in support of anaphylaxis and plans to request a pre-NDA meeting with the FDA in the third quarter of 2024.
Price Trends: AQST shares were up 0.26% at $2.44 as of last check on Tuesday.
Photo by Evan Roan, Shutterstock
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This article Emergency oral allergy medication – Data shows Aquestive Therapeutics’ investigational drug remains effective even when exposed to liquids at different temperatures Originally Benzinga
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