Lexaria Bioscience (NASDAQ: LEXX, LEXXW), a global innovator in drug-delivery platforms, is planning to submit an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) in the next 45 days. The application is for the company’s planned U.S. phase 1b Hypertension Clinical Trial. The filing had been delayed for necessary documentation from a raw material supplier, which is now being provided, enabling Lexaria to finalize the IND application. According to the announcement, the supplier anticipates providing the final two pieces of outstanding information to the FDA within the next 45 days, after which Lexaria can proceed with filing the IND application. The trial, which is titled “A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of DehydraTECH-CBD(TM) in Subjects with Stage 1 or Stage 2 Hypertension,” is designed to evaluate safety and tolerability in hypertensive patients. Secondary objectives of the study will include efficacy evaluation in reducing blood pressure together with detailed pharmacokinetic testing. “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, that it’s proposed phase 1b study plan will not expose test subjects to unreasonable risk,” the company stated in the press release. “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.”
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About Lexaria Bioscience Corp.
Lexaria Bioscience’s patented drug-delivery formulation and processing platform technology, DehydraTECH(TM), 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 bioabsorption 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 37 patents granted and many patents pending worldwide. For more information about the company, please visit www.LexariaBioscience.com.
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