Lexaria Applauds FDA Decision on Reduced Risk Tobacco Format
KELOWNA, BC / ACCESSWIRE / October 24, 2019 / Lexaria Bioscience Corp. (OTCQX:LXRP) (CSE:LXX) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is very pleased to report that, for the first time ever, the Food and Drug Administration (the "FDA") has authorized the marketing of oral nicotine products through the Modified Risk Tobacco Product pathway, including product categories that could benefit from Lexaria's technology.
The product format authorized by the FDA is in the tobacco pouch category, similar to a mini tea-bag that is held in the mouth from which the nicotine within is absorbed. Unlike chewing tobacco, there is no need to spit. The tobacco pouch category is very popular in parts of Europe where it is one of the fastest growing product formats.
Significant is that there is no combustion, heating or vaporization of the tobacco pouch during use. Because of this and the scientific evidence accepted by the FDA that included long-term epidemiological studies in association with this approval, claims of a lower risk of mouth cancer, stroke, lung disease, heart disease, emphysema and chronic bronchitis than cigarettes are permitted by the FDA.
"Lexaria applauds this informed and forward-looking decision by the FDA to recognize improvements in delivery formats that are being made by industry," said Chris Bunka, Chief Executive Officer of Lexaria Bioscience Corp. "Lexaria realized long ago that DehydraTECHTM could empower alternative nicotine product formats and as a result our delivery technology which is already patented in the US and patent pending around the world for enhanced oral nicotine delivery."
Lexaria believes that, as regulatory agencies around the world are presented with the latest scientific data and become informed of the new technologies available, they will continue to recognize the reduced risks now possible with this and other potential oral formats. Lexaria intends to position its DehydraTECHTM nicotine delivery technology as one of the world's leading alternatives to smoking or vaping.
DehydraTECH technology is already industry-proven in the CBD/hemp industry at being one of the most effective and consumer preferred methods ever devised to deliver active ingredients in an oral form. Lexaria's research and product development includes a formal human clinical trial that produced results significant enough to be recently published in a peer-reviewed US medical journal. Lexaria previously published positive findings from studies evidencing the ability of DenydraTECH to significantly increase the speed and extent of oral absorption of nicotine.
Lexaria believes that oral forms of nicotine delivery can be a positive contributor to methods of reduced-risk access to nicotine with far superior health outcomes to traditional combustible cigarettes. In both human clinical studies and in animal studies, DehydraTECH has repeatedly demonstrated its ability to enhance the bio-absorption and bioavailability performance of beneficial compounds in ingestible products. Lexaria's patented DehydraTECH technology could offer the world enhanced satisfactory oral nicotine delivery and usher in a new era of reduced-risk nicotine use through enhanced consumer choices.
Lexaria Bioscience Corp. is a global innovator in drug delivery platforms. Its patented DehydraTECH™ drug delivery technology changes the way Active Pharmaceutical Ingredients enter the bloodstream, promoting healthier ingestion methods, lower overall dosing and higher effectiveness for lipophilic active molecules. DehydraTECH increases bio-absorption; reduces time of onset; and masks unwanted tastes for orally administered bioactive molecules including cannabinoids, vitamins, non-steroidal anti-inflammatory drugs (NSAIDs), nicotine and other molecules. Lexaria has licensed DehydraTECH to multiple companies in the cannabis industry for use in cannabinoid beverages, edibles and oral products; and to a world-leading tobacco producer for the development of smokeless, oral-based nicotine products. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 16 patents granted and over 60 patents pending worldwide.
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FOR FURTHER INFORMATION PLEASE CONTACT:
Lexaria Bioscience Corp.
Alex Blanchard, Communications Manager
(250) 765-6424 ext. 202
This release includes forward-looking statements. Statements which are not historical facts are forward-looking statements. The Company makes forward-looking public statements concerning its expected future financial position, results of operations, cash flows, financing plans, business strategy, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, including statements that include words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions are forward-looking statements, including but not limited to: that any additional patent protection will be realized or that patent achievements will deliver material results. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that other factors will not affect the accuracy of such forward-looking statements. Factors which 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, the patent application and approval process and other factors which may be identified from time to time in the Company's public announcements and filings. There is no assurance that existing capital is sufficient for the Company's needs or that it will be able to raise additional capital. There is no assurance the Company will be capable of developing, marketing, licensing, or selling edible products containing nicotine or any other active ingredient. There is no assurance that any planned corporate activity, scientific research or study, business venture, letter of intent, technology licensing pursuit, patent application or allowance, consumer study or any initiative will be pursued, or if pursued, will be successful or completed. 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 in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease.
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SOURCE: Lexaria Bioscience Corp.
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Released October 24, 2019