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Lexaria Provides Update on Human Nicotine Study NIC-H22-1
Lexaria's DehydraTECH-nicotine pouch performance will be compared to existing leading brands currently sold in the United States such as ON! and ZynKELOWNA,
About this update from Lexaria Bioscience Corp.
[{"type":"text","content":"Lexaria's DehydraTECH-nicotine pouch performance will be compared to existing leading brands currently sold in the United States such as ON! and ZynKELOWNA, BC / ACCESSWIRE / April 12, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the \"Company\" or \"Lexaria\"), a global innovator in drug delivery platforms, announces details of human nicotine study NIC-H22-1, which is expected to begin dosing this summer.Study NIC-H22-1 is a minimum 36-person human pharmacokinetic (\"pk\") randomized, double blinded, cross-over study to compare Lexaria's DehydraTECH-nicotine pouch performance to that of existing leading brands currently sold in the US such as ON! and Zyn. Objective data collection from blood samples that will evidence Tmax, Cmax, and AUC is the primary objective of the study. Secondary objectives include extensive subjective evaluations related to throat burn, user experience, and more. Lexaria hopes to evidence that processing purified nicotine with DehydraTECH leads to better oral-tissue absorption and reduced negative experiences compared to currently sold brands.The design phase of study NIC-H22-1 is complete and test articles are currently being manufactured. The Company will announce when dosing begins, which is expected this summer. This study is funded by Lexaria with existing capital. The Company is optimistic that this larger human study will produce positive findings pursuant to those evidenced in its previous 2021 subjective human testing that utilized DehydraTECH-nicotine formulations demonstrating onset of initial nicotine effectiveness in as little as 1.5 to 4 minutes after an oral dose.As reported on October 5, 2021, Lexaria demonstrated in animal study NIC-A21-1 that nicotine oral pouches using DehydraTECH technology were 10x to 20x faster in reaching peak delivery of nicotine to bloodstream than controls. Findings using a DehydraTECH nicotine benzoate formulation relative to a concentration-matched control from that study are shown in the figure above.The oral nicotine pouch category is of intense interest to Lexaria and is one of the fastest growing segments of the nicotine industry due in part to its reduced risk health outcomes as noted by the Food and Drug Administration (\"FDA\"). This delivery method, in the white pouch format specifically, which avoids harmful lung outcomes experienced b...