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Lexaria Provides Update on Investigational New Drug Application Progress
KELOWNA, BC / ACCESSWIRE / August 30, 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 / August 30, 2023 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the \"Company\" or \"Lexaria\"), a global innovator in drug delivery platforms, is providing this update on the status of 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 designated as HYPER-H23-1.As previously reported, work that was mostly under Lexaria's control such as batch manufacturing of DehydraTECH™-processed cannabidiol and placebo materials necessary for the IND application filing was completed earlier this year, followed by analytical release and ongoing stability testing.In parallel, compilation of the large set of documentation necessary for inclusion in the IND filing has been progressing on time by the Company and its service providers. However, work that is outside of Lexaria's control, namely the provision of required documentation by one of Lexaria's material suppliers related to their analytical and stability testing of their material, has been delayed. Accordingly, Lexaria is not in a position to submit the IND package to the FDA for their review and consideration until these delays have been cured by the supplier.Lexaria is in communication with its material supplier to provide their required information as soon as possible but, as at the current date, we have not received the results nor an estimated time of receipt for same. Lexaria continues to finalize the IND application so that the Company is in a position to file with the FDA as soon as possible following receipt of the outstanding information and will provide updated details regarding the status of its IND application filing as they become available.Background and Medical/Market RationaleLexaria's five previous human clinical studies of DehydraTECH-CBD in hypertension conducted from 2018 through 2022, which were not conducted under FDA-registration but are integral to successful filing and review of its planned IND submission, were carried out in an aggregate total of 134 healthy and hypertensive persons. These foundational 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 Dehy...