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Lexaria Receives Independent Review Board Approval for its Upcoming Human Oral Nicotine Study
Lexaria's DehydraTECH-nicotine pouch performance to be compared to existing leading brands ON! and ZynKELOWNA, BC / ACCESSWIRE / November 1, 2022 / Lexaria
About this update from Lexaria Bioscience Corp.
[{"type":"text","content":"Lexaria's DehydraTECH-nicotine pouch performance to be compared to existing leading brands ON! and ZynKELOWNA, BC / ACCESSWIRE / November 1, 2022 / Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the \"Company\" or \"Lexaria\"), a global innovator in drug delivery platforms is pleased to announce that independent review board (\"IRB\") approval has now been received for human clinical nicotine study NIC-H22-1, and that human dosing will begin soon.Study NIC-H22-1 is a 36-person human pharmacokinetic (\"pk\") randomized, double blinded, cross-over study conducted in current cigarette smokers, wherein each person will visit the laboratory to be dosed three times over a period of weeks. During each visit only one oral nicotine pouch will be administered and evaluated: either DehydraTECH-nicotine; On! brand manufactured by Altria; or Zyn brand manufactured by Swedish Match. Predetermined questionnaires for subjective evaluation will be used for each oral nicotine pouch, and blood samples will be taken a total of 8 times per visit to conduct objective evaluations related to quantity of nicotine in blood at various time points, and more. Vital signs such as temperature, blood pressure, heart rate and respiratory rate will also be collected. Subjective evaluations related to throat burn, user experience, gastrointestinal experience and more will be conducted. 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 study had earlier faced certain time extensions due to manufacturing and logistics, those issues since resolved. The study is fully funded from internal company resources. Lexaria will provide further updates and any relevant material findings in due course from this study as they become available.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 below.The oral nicotine pouch category is of intense interest to Lexaria and is one of the fastest growing segments of the nicotine i...