Lexaria Announces Positive Feedback from Pre-IND Meeting with FDA on DehydraTECH-CBD for Hypertension

Important milestone achieved in the commercial product development program
Abbreviated 505(b)(2) strategy confirmed as appropriate NDA pathway

KELOWNA, BC / ACCESSWIRE / August 10, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms, is pleased to announce that it has received a full positive written response from the Food and Drug. Administration (“FDA”) of its Pre-Investigational New Drug (“Pre-IND”) meeting on DehydraTECH-CBD for the treatment of hypertension.

The FDA confirmed that it agreed with Lexaria’s proposal to pursue a 505(b)(2) new drug application (“NDA”) regulatory pathway for your program, which is advantageous because this shortcut, as it is often described, typically allows for a faster route to commercial approval than the traditional 505(b)(1) NDA pathway .

Lexaria’s proposed Phase Ib clinical protocol for DehydraTECH-CBD for the treatment of a target of 100 patients with hypertension was favorably received by the FDA, with the goal of opening the IND application to allow Lexaria to work for the full registration of DehydraTECH-CBD for the treatment of hypertension.

“We are very pleased to have received feedback from the FDA regarding the opening of our IND program and will immediately execute an IND enabling work confirmed by the FDA,” said John Docherty, president of Lexaria Bioscience Corp. “We are delighted that our proposals were so well received by the FDA and the feedback received will be very helpful in compiling and submitting our IND application as the next important regulatory step we are focused on moving forward.”

Additionally, as part of the communication with the FDA, it agreed that additional non-clinical studies are not required prior to initiation of the DehydraTECH-CBD IND program, given the compelling data already presented by Lexaria and others on the safety and the tolerability of CBD. This supports Lexaria’s long-held belief that its recent human clinical study program would support our eventual FDA registration activities.

As a result of the FDA’s favorable response, Lexaria expects to be on track to submit its full IND application to the FDA in late 2022/early 2023, as previously announced. This is up to 6-9 months earlier than if the FDA had required modifications to Lexaria’s current work plan for the IND, such as conducting additional non-clinical study work.

DehydraTECH-CBD is protected by multiple patents in the US and internationally and has received specific patent protection in both the EU and Australia for use in the treatment of heart disease. Lexaria continues to investigate all opportunities within the heart disease sector, including hypertension, arterial stiffness and more.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.’s patented drug delivery technology, DehydraTECHâ„¢, improves how active pharmaceutical ingredients (APIs) enter the bloodstream promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bioabsorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also demonstrated the ability to deliver some drugs more effectively across the blood-brain barrier. Lexaria operates an in-house licensed research laboratory and has a strong intellectual property portfolio with 26 granted patents and approximately 50 patents pending worldwide. For more information, visit www.lexariabioscience.com.


This press release includes forward-looking statements. Statements as a term are defined in the applicable securities laws. These statements can be identified by words such as “anticipate,” “if,” “believe,” “plan,” “estimate,” “expect,” “attempt,” “could,” “could,” “should,” “will” and other similar expressions. These forward-looking statements in this press release include, but are not limited to, company statements related to the company’s ability to conduct research initiatives, receive regulatory approvals or grants, or experience positive effects or results from any research or study These forward-looking statements are estimates that reflect the company’s best judgment based on current information and involve a number of risks and uncertainties, and there can be no assurance that the company will actually achieve the plans, intentions or expectations disclosed in these forward-looking projections. statements As such, you should not place undue reliance on these forward-looking statements. Factors that could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation , competition, scientific discovery, patent application. and the approval process, potential adverse effects arising from testing or use of products using DehydraTECH technology, the Company’s ability to maintain existing partnerships and realize benefits, delays or cancellations of planned R&D that may occur related to pandemics or for other reasons, and other factors that may be identified from time to time in the Company’s public announcements and periodic filings with the Securities and Exchange Commission of the US on EDGAR. There is no assurance that any of Lexaria’s postulated uses, benefits or advantages for the patented and patent-pending technology will in fact be realized in any manner or anywhere. The Food and Drug Administration (FDA) has not evaluated any claims made here. Products associated with Lexaria are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, events futures, changed circumstances or otherwise. , unless otherwise required by law.

George Jurcic – Head of Investor Relations
Phone: 250-765-6424, ext. 202

SOURCE: Lexaria Bioscience Corp.

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