DehydraTECH-Nicotine reaches maximum blood saturation levels faster than world-leading brands from Swedish Match and Altria in human study NIC-H22-1
Noteworthy superior subjective performance characteristics also observed
Kelowna, British Columbia – TheNewswire – 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:
“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|
|on! oral pouch||17.67||121%|
|Nasal spray||up to 18||up to 125%|
|ZYN oral pouch||18.48||131%|
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.
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.
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.
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