Lexaria Bioscience (NASDAQ: LEXX, LEXXW), a global innovator in drug-delivery platforms, has submitted its much-anticipated Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”). The application covers HYPER-H23-1, the company’s upcoming planned U.S. phase 1b hypertension clinical trial of DehydraTECH-CBD. According to the announcement, the company had a successful pre-IND meeting with FDA officials. Following the guidance provided in that meeting regarding the development and filing of the IND, the company submitted the application on Jan. 29, 2024. The company will now wait 30 calendar days before initiating any clinical trials, in compliance with FDA guidelines. During that 30-day period, the FDA may review the IND for safety concerns. The primary focus of the trial will be to evaluate safety and tolerability in hypertensive patients with secondary goals including to study the efficacy of reducing blood pressure together with detailed pharmacokinetic testing. “Lexaria looks forward to commencing clinical trial HYPER-H23-1 as soon as possible following IND effectiveness, subject to certain conditions, including funding,” the company stated in the press release. “The IND review process when successfully concluded will be an important milestone achievement for Lexaria demonstrating that its DehydraTECH technology has met high-level formal regulatory scrutiny towards prospective future pharmaceutical commercial registration.”
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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 38 patents granted and many patents pending worldwide. For more information about the company, please visit www.LexariaBioscience.com.
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