KELOWNA, BC / ACCESSWIRE / August 9, 2023 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms is pleased to report results from its 2023 human oral nicotine study NIC-H22-1 comparing Lexaria’s DehydraTECH™-Nicotine tobacco-free pouch to world-leading brands ZYN® (from Swedish Match) and on!® (from Altria Group Inc’s subsidiary Helix Innovations LLC).
Lexaria’s oral nicotine pouch was statistically significantly faster in the median time required to reach comparable maximum nicotine concentrations within the bloodstream (“Tmax”), than both on! and ZYN. DehydraTECH-Nicotine was 15.0% faster in reaching Tmax levels than on! and 20.2% faster than ZYN:
| Lexaria | on! | ZYN | |
| Tmax (minutes) | 15.37 | 17.67p=0.004 | 18.48p=0.000 |
“With just five short years of R&D and product development, Lexaria has been able to develop an oral nicotine product that meets or exceeds the performance of the world’s leading existing brands,” said Chris Bunka, CEO of Lexaria Bioscience. “This is a remarkable achievement that speaks to the capabilities of the DehydraTECH technology and also to the Lexaria R&D team, working ardently with scarce resources relative to global multi-billion-dollar behemoths. We’ve always had an overwhelming determination and fierce conviction that we can make the world a better place and reduce the carnage caused by smoked cigarettes, and now we have human study data that demonstrates advantages of DehydraTECH processed nicotine relative to the competitive landscape.”
According to a pharmacokinetic study, both combustible cigarettes and “heat-not-burn” tobacco-containing devices require roughly 8 minutes to reach Tmax. Using this standard cigarette Tmax delivery time as a base, the ZYN pouch was 131% slower and the on! pouch was 121% slower than a smoked cigarette to reach Tmax. The Tmax times of a number of nicotine product formats at comparable dose levels used in study NIC-H22-1 are shown in the table below, taken from the published 2009 study Nicotine Chemistry, Metabolism, Kinetics and Biomarkers, showing the relative Tmax time delay (%) per product compared to cigarette use. Generally speaking, rapid delivery of nicotine is a vital component of the potential for product adoption for use by consumers.
| Product | Tmax (mins) | Percent Time Delay |
| Combusted cigarette | 8.0 | – |
| on! oral pouch | 17.67 | 121% |
| Nasal spray | up to 18 | up to 125% |
| ZYN oral pouch | 18.48 | 131% |
| Subcutaneous injection | 25 | 213% |
| Gum | 30.0 | 275% |
| Lozenge | 60.0 | 650% |
| Oral solution | 66 | 725% |
| DehydraTECH-Nicotine oral pouch | 15.37 | 92% |
Avoiding or minimizing harm is a major objective of oral nicotine products. Another study reported that heat-not-burn devices delivered as much as 27.9% of the same harmful and potentially harmful constituents delivered by combusted cigarettes. These include substances such as nitrosamines and polycyclic aromatic hydrocarbons such as benzene. By comparison, non-combusted oral nicotine pouch products with no tobacco and nicotine replacement therapies, have been shown to deliver non-quantifiable levels of these harmful substances for superior safety and tolerability. The FDA has indeed issued a reduced-risk notice for smokeless type products.
Subjective Analyses
Detailed questionnaires were administered to all participants in the study, for each test article, to assess subjective effects and determine the “human experience” while using the products. While the findings lacked statistical significance in most instances, possibly due to sample size limitations, a number of intriguing data trends were observed.
In general, the fact that the Tmax was faster with Lexaria compared to both on! and ZYN, seemed to support apparent trends towards higher levels of certain pleasurable effects, sooner, with the Lexaria product. Conversely, the lowest frequency of certain unwanted negative effects such as moderate to severe nausea were reported from the Lexaria product users, demonstrative of some of the patented formulation benefits of Lexaria’s DehydraTECH.
- Euphoria and Head Rush. The highest percentage of users reporting that they felt euphoric at all time points were the Lexaria users; and the highest percentage of users reporting they felt a head rush at the 5 and 30-minute marks were also Lexaria users.
- Tolerability. The highest endorsement score for users reporting “I tolerated this product well” were the Lexaria users, with statistical significance demonstrated at the second dosing visit in particular (p=0.007).
- Pleasure. The highest percentage of users reporting that they considered the experience “pleasurable” at the 30-minute mark were the Lexaria users, while the on! users reported the lowest percentage as “pleasurable” at this point.
- Mouth and Throat-burn. Lexaria scored best for percent enjoyment of the nicotine induced burning sensation in the mouth and throat. The highest percentage of severe mouth and throat-burn events were reported by users of the on! pouch.
- Nausea. The highest frequency of moderate and severe nausea effects were reported by users of the ZYN and on! pouches respectively; with the lowest frequency reported by users of the Lexaria pouch.
- Hiccups. Moderate to severe hiccups were only reported by users of the on! and ZYN products.
Lexaria’s recent US patent award covering its novel oral-nicotine formulations powered by DehydraTECH only adds to the value of Lexaria’s nicotine strategies and erects hurdles against would-be copycat industry participants. Further product development and optimization work could lead to increased performance to DehydraTECH-Nicotine. For example, both on! and ZYN are understood to utilize nicotine bitartrate dihydrate as their nicotine raw material inputs whereas Lexaria’s formulation for this study utilized nicotine benzoate. Study work in animals has shown apparent trends toward much higher peak blood level delivery following nicotine tartrate injection compared to nicotine benzoate injection, opening the door to the possibility of even higher performance gains if DehydraTECH processing was used with nicotine bitartrate dihydrate.
Lexaria will now seek to commercialize DehydraTECH-Nicotine with suitable industry partners based on its clinical and intellectual property advancements.
About Nicotine Study NIC-H22-1
A randomized, double-blind, crossover study design was employed, involving 36 participants who were long time heavy cigarette smokers, smoking at least 10 cigarettes per day. The three nicotine pouches under evaluation were labelled 1, 2, and 3 to maintain blinding. The nicotine pouches compared to Lexaria’s DehydraTECH-Nicotine pouch were on! and ZYN brands, with laboratory testing performed to verify 3mg of nicotine in each pouch. Each product had a spearmint flavor and all participants used each product for a predetermined period, with washout periods of 2-7 days in between uses across three separate study visits to minimize carryover effects. Subjective effects, both positive and adverse, were assessed at baseline, 5 minutes, 30 minutes, and 120 minutes using a questionnaire to capture 25 different effects. A battery of different product details as well as adverse events of special interest were also assessed at each study visit. Venous blood for pharmacokinetic (PK) analyses was drawn at baseline and minutes 5, 10, 15, 30, 45, 60, and 120. PK parameters evaluated were area under the curve , maximum plasma concentration , and time to reach the maximum plasma concentration (Tmax). All clinical and laboratory procedures for study NIC-H22-1 were performed entirely by U.S.-based, third-party independent contract service providers.
About DehydraTECH
DehydraTECH is a patented drug delivery formulation and processing platform technology Lexaria has developed and is investigating for a variety of beneficial molecules. DehydraTECH is designed to improve the way active molecules enter the bloodstream upon oral ingestion. DehydraTECH has also demonstrated enhanced delivery of certain active molecules into brain tissue, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria has also developed DehydraTECH formulations for other applications demonstrating superior bio-absorption when administered intraorally and topically.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.’s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 35 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.
CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as “anticipate,” “if,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “could,” “should,” “will,” and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the Company relating the Company’s ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. 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 the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these 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, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company’s ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company’s public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. 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. 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 or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
INVESTOR CONTACT:
George Jurcic – Head of Investor Relations
ir@lexariabioscience.com
Phone: 250-765-6424, ext 202
SOURCE: Lexaria Bioscience Corp.
Company Relationship Disclosure
OTB is responsible for the OTB opinions provided in this disclosure except all sources or information provided by other parties were not verified or authenticated and OTB does not undertake to confirm or substantiate or be responsible for such information provided by other parties.
Any Content posted regarding a Profiled Issuer is not a solicitation or recommendation to buy, sell or hold securities. We cannot and do not assess, verify or guarantee the adequacy, accuracy or completeness of any information, the suitability or profitability of any particular investment, or the potential value of any investment or informational source. All information should be independently verified. We are not responsible for errors or omissions in our publications, and any opinions expressed are subject to change, without notice. We do not, nor are we under any obligation to undertake due diligence or investigation or authenticate and verify whatsoever regarding Profiled Issuers or any Content posted in relation thereto and we do not receive any verification from the Profiled Issuer regarding the Content we disseminate. Similarly, while we endeavor to facilitate the provision of quality information, we are not responsible for any loss or damages caused or alleged to have been caused by its use nor verify or authenticate or update such information.
Pursuant to an agreement between Spotlight Media and Lexaria Bioscience we have been hired for a period of 30 days beginning July 10, 2023 and ending August 10, 2023 to publicly disseminate information about Lexaria Bioscience including on the Website and other media including Facebook and Twitter. We are being paid $1,000 per month by Lexaria Bioscience and were paid “ZERO” shares of unrestricted or restricted common shares. We plan to sell the “ZERO” shares of Lexaria Bioscience that we hold during the time the Website and/or Facebook and Twitter Information recommends that investors or visitors to the website purchase without further notice to you. We may buy or sell additional shares of Lexaria Bioscience in the open market at any time, including before, during or after the Website and Information, provide public dissemination of favorable Information.
This article contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs regarding future performance are “forward-looking statements”. Forward-looking statements can be identified by the use of words such as “expects”, “does not expect”, “is expected”, “believes”, “intends”, “anticipates”, “does not anticipate”, “believes” or variations of these words, expressions or statements, that certain actions, events or results “may”, “could”, “would”, “might” or “will be” taken, will occur or will be realized. Such forward-looking statements involve risks, uncertainties and other known and unknown factors that could cause actual results, events or developments to differ materially from the results, events or developments expected and expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, dependence on obtaining and maintaining regulatory approvals, including the acquisition and renewal of federal, provincial, state, municipal, local or other licenses, and any inability to obtain all necessary government authorizations, licenses and permits to operate and expand the Company’s facilities; regulatory or policy changes such as changes in applicable laws and regulations, including federal, state and provincial legalization, due to fluctuations in public opinion, industry perception of integrative mental health, including the use of psychedelic-assisted therapy, delays or inefficiencies or any other reason; any other factor or development likely to hamper the growth of the market; the Company’s limited operating and profitability track record; dependence on management; the Company’s need for additional financing and the effects of financial market conditions and other factors on the availability of capital; competition, including that of more established and better funded competitors; the impact of the Russia-Ukraine conflict on the global economy; the continued impact of the COVID-19 pandemic; and the need to build and maintain alliances and partnerships, including with research and development companies, customers and suppliers. These factors should be carefully considered, and readers are cautioned not to place undue reliance on forward-looking statements. Despite the Company’s efforts to identify the main risk factors that could cause actual measures, events or results to differ materially from those described in forward-looking statements, other risk factors may cause measures, events or developments to materially differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company does not undertake to revise forward-looking statements, even if new information becomes available as a result of future events, new facts or any other reason, except as required by applicable laws
