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Lexaria's Investigational New Drug Application Filing Update
KELOWNA, BC / ACCESSWIRE / December 7, 2023 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug
About this update from Lexaria Bioscience Corp.
[{"type":"text","content":"KELOWNA, BC / ACCESSWIRE / December 7, 2023 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the \"Company\" or \"Lexaria\"), a global innovator in drug delivery platforms, announces that the Company's anticipated submission of an Investigational New Drug (\"IND\") application with the U.S. Food and Drug Administration (\"FDA\") for its planned U.S. Phase 1b Hypertension Clinical Trial is expected to be filed within approximately 45 days.As previously announced, this filing was regrettably delayed while Lexaria awaited overdue documentation from one of its key raw material suppliers. Lexaria is pleased to announce that the supplier in question has updated much of this documentation with Lexaria and directly with the FDA, which will now enable Lexaria to complete final integration of this information into its IND application. The supplier has recently informed Lexaria that, within approximately 45 days, it expects to submit its two final pieces of outstanding information with the FDA, following which Lexaria will be able to proceed with filing our IND application.Lexaria feels confident, given that from 2018 through 2022 it has previously conducted five human clinical trials studying DehydraTECH-CBD in an aggregate total of 134 people, without recording a single serious adverse event (the \"Studies\"), that it's proposed Phase 1b study plan will not expose test subjects to unreasonable risk. Lexaria looks forward to submitting this important IND filing and hopes that the review process proceeds smoothly toward effectiveness in the subsequent 30 day period allotted by the FDA.Background and Medical/Market RationaleThe Studies, which were not conducted under FDA-registration but are integral to successful filing and review of Lexaria's planned IND submission, were carried out in an aggregate total of 134 healthy and hypertensive persons. The Studies evidenced significant reductions in resting blood pressure over both acute and multi-week dosing regimens, and also produced zero serious adverse events; suggesting that DehydraTECH-CBD has the potential to have pronounced clinical benefits relative to available anti-hypertensive therapeutics.Lexaria is aware of only a handful of other published research studies, mostly in young, healthy and normotensive volunteers, that have investigated whether a sustained decrease in resting b...