Lexaria Bioscience (NASDAQ: LEXX, LEXXW), a global innovator in drug delivery platforms, today provided an update on the status of its anticipated submission of an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) for the company’s planned U.S. phase 1b hypertension clinical trial designated as HYPER-H23-1. As previously announced, work that was mostly under Lexaria’s control such as batch manufacturing of DehydraTECH(TM)-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, the company and its service providers have been progressing with compilation of the documentation necessary for inclusion in the IND filing on time. However, work outside of Lexaria’s control, namely the provision of required documentation by one of the company’s material suppliers related to analytical and stability testing of material, has been delayed.
As a result, Lexaria is not in a position to submit the IND package to the FDA for review and consideration until the supplier cures these delays. Lexaria is in communication with its material supplier to provide the required information as soon as possible but, to date, has not received the results nor an estimated time of receipt. Lexaria continues to finalize the IND application to be 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.
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About Lexaria Bioscience Corp.
Lexaria’s patented drug delivery technology, DehydraTECH(TM), improves the way active pharmaceutical ingredients (“APIs”) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 35 patents granted and many patents pending worldwide. For more information, visit the company’s website at www.LexariaBioscience.com.
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