Lexaria Bioscience (NASDAQ: LEXX, LEXXW), a global innovator in drug delivery platforms, today announced that the U.S. Food and Drug Administration (“FDA”) has confirmed the effectiveness of the company’s investigational new drug (“IND”) application thereby clearing Lexaria to conduct its planned U.S. Phase 1b hypertension clinical trial HYPER-H23-1 utilizing DehydraTECH-CBD. According to the announcement, the company is pleased to have complied with the FDA’s rules and procedures for clearance to perform this important registrational trial. The company will further announce when it is ready to begin the study, subject to certain conditions, including raising sufficient funding. “This is a significant milestone achievement for Lexaria demonstrating, for the first time, that its DehydraTECH technology meets the FDA’s high level of regulatory scrutiny sufficient to formally commence U.S. registrational clinical testing towards possible future pharmaceutical commercialization,” said John Docherty, president of Lexaria. “We look forward to commencing this important clinical trial and building upon the wealth of early stage clinical data we have gathered and presented to the FDA to date demonstrating the safety, efficacy and novel mechanistic performance of DehydraTECH-CBD in hypertensive patients.”
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About Lexaria Bioscience Corp.
DehydraTECH(TM) is Lexaria’s patented drug delivery formulation and processing platform technology that improves the way active pharmaceutical ingredients (“APIs”) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 39 patents granted and many patents pending worldwide. For more information, visit the company’s website at www.LexariaBioscience.com.
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