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Lexaria Achieves Significant Breakthrough in Alternative Nicotine Delivery Technology Kelowna, British Columbia

Key Takeaway: Lexaria Achieves Significant Breakthrough in Alternative Nicotine Delivery Technology Kelowna, British Columbia April 17, 2018 Lexaria Bioscience Corp. (OTCQX: LXRP) (CSE: LXX) (the Company or Lexaria ), a drug delivery platform innovator, is pleased to announce positive topl

Full Press Release Details

Lexaria Achieves Significant Breakthrough in Alternative
Nicotine Delivery Technology
Kelowna, British Columbia April 17, 2018 Lexaria Bioscience
Corp. (OTCQX: LXRP) (CSE: LXX) (the Company or Lexaria ), a drug delivery
platform innovator, is pleased to announce positive topline results upon
completion of its first ingestible nicotine in vivo (animal) absorption
study. Lexaria is pursuing the use of its patented DehydraTECHTM
technology as a possible new nicotine delivery method, an edible dose absorbed
through the gastrointestinal tract, with potential both as a nicotine
replacement therapy as well as an alternative product format for regular tobacco
DehydraTECHTM delivered the following major nicotine
absorption performance improvements:
1,160% faster delivery of equivalent peak quantities of nicotine to the
bloodstream than achieved with controls (within 15 min vs. 2.9 hours);
148% gain in the quantity of peak nicotine delivery to the bloodstream
relative to controls;
560% higher brain levels of nicotine where nicotine effects are focused,
compared to controls;
Lower urine levels of nicotine excreted than controls, for enhanced
nicotine activity and bioavailability over the course of the study;
Lower quantities of key liver metabolites in the bloodstream than controls
as hypothesized, suggesting bypass of first pass liver metabolism.
Study Design Parameters:
The study was designed to principally assess the relative
ingestible nicotine absorption performance of DehydraTECHTM-powered
formulations compared to concentration-matched control formulations that lacked
any form of delivery enabling technology in rats. Nicotine was administered in a
nicotine polacrilex derivative format as is widely commercialized today in
nicotine replacement therapy products such as chewing gums. Twelve male rats
were divided into four groups of three, such that DehydraTECHTM and
control formulations were each tested at a 1 mg/Kg and 10 mg/Kg dosage level.
Formulations were administered orally and all rats were cannulated for blood
collection at multiple intervals over an 8 hour duration post-dosing with the
first data collection at the 15-minute mark. Urine and feces were also collected
for up to a 24-hour duration post-dosing, and essential organ tissue samples
were also collected for examination after the study. All samples were subjected
to analytical testing in order to quantify the levels of nicotine therein, as
well as the levels of three major liver metabolites thereof, hydroxycotinine,
nicotine N -oxide and cotinine, in order to assess the relative metabolite levels absorbed by the different formulations. Lexaria's hypothesis was tested to prove that its DehydraTECHTM technology would influence more rapid and complete intestinal bioabsorption of nicotine lymphatically with
less metabolic degradation by the liver. All animals were also assessed for general tolerability of the administered formulations. The study was conducted at the same independent laboratory in Philadelphia where the Company completed its initial
cannabidiol absorption study in 2015.
Results & Observations:
The Lexaria formulations generally achieved faster absorption, higher peak absorption and higher overall quantities of nicotine, on average, in the blood than the concentration-matched control formulations at both the 1mg and 10 mg/Kg doses tested.
Furthermore, as previously reported, there were no obvious signs of gastrointestinal distress such as vomiting or diarrhea indicating that the animals appeared to tolerate the treatment well.
Nicotine blood levels were evaluated multiple times over a period of 8 hours after dosing. In the 10mg/Kg dosing arm, the control formulation required nearly 3 hours to reach similar levels of blood absorption that the Lexaria formulation reached in
only 15 minutes. Furthermore, the Lexaria formulation went on thereafter to demonstrate peak plasma levels that were 148% of those achieved by the control formulation. If replicated in human studies, these findings are suggestive that
Lexaria's technology could prove more effective in elevating blood nicotine levels through edible formats much more quickly and substantially than previously theorized, potentially making ingestible nicotine preparations a viable alternative
to today's available product formats while also leading to a more rapid nicotine craving satiation.
Analysis of the liver metabolites revealed, as expected, that overall levels in the blood of two of the three metabolites studied were higher in the control group than in the Lexaria formulation group at the 10 mg/Kg dose. This result was especially
pronounced in the 45-minute to 2-hour time interval post-dosing which is consistent with the expected timing of release of metabolites in higher quantity into the bloodstream by the liver following normal physiological processing of ingested
nicotine with the control preparation, compared to the DehydraTECHTM technology that is believed to elude first pass liver metabolism. The Lexaria formulation also demonstrated lower quantities of nicotine in the rat urine at both doses,
which is consistent with the fact that the levels of nicotine in the rat blood remained higher over the duration of the study with the Lexaria formulation than with the control. The study also revealed that the Lexaria formulation at the 10 mg/Kg
level achieved up to 5.6 -times as much nicotine upon analysis of the rat brain tissue than was recovered with the matching control formulation. These findings together perhaps suggest prolongation of nicotine effectiveness
with the Lexaria formulation which may also be beneficial in humans to control
cravings over an extended time-period from a single edible nicotine dose.
We are very pleased with these topline study findings
demonstrating excellent tolerability and substantially faster, more potent and
bioavailable absorption of nicotine in an ingestible format with our
DehydraTECHTM technology than controls, said John Docherty,
President. This data supports further investigation of the many possible
benefits of our DehydraTECHTM technology for nicotine delivery with
potential both as a nicotine replacement therapy as well as an alternative
product format for regular tobacco users over today s inhaled options.
Further analysis of the existing data is required, and
additional datasets from the study are still being processed and have not yet
been received by Lexaria. New studies are being planned to pursue investigatory
Lexaria s patented DehydraTECH technology is focused on
improved delivery methodologies of many commonly used active
pharmaceutical ingredient ( API ) substances. As such, it provides an additional
layer of effectiveness that is designed to harmonize with the intellectual
property of third parties. Both patented and generic API substances can utilize
Lexaria s patented technology. Lexaria s long term strategy is to partner with
the world s leading firms as they deliver best-of-class products to their
existing large consumer groups.
Lexaria Bioscience Corp. has developed
and out-licenses its disruptive delivery technology that promotes healthier
ingestion methods, lower overall dosing and higher effectiveness of lipophilic
active molecules. Lexaria has multiple patents pending in over 40 countries
around the world and has patents granted in the USA and in Australia for
utilization of its DehydraTECHTM delivery technology. Lexaria s
technology provides increases in intestinal absorption rates; more rapid
delivery to the bloodstream; and important taste-masking benefits, for orally
administered bioactive molecules including cannabinoids, vitamins, non-steroidal
anti-inflammatory drugs (NSAIDs), nicotine and other molecules. www.lexariabioscience.com
For regular updates, connect with Lexaria on Twitter (https://twitter.com/lexariacorp)
FOR FURTHER INFORMATION PLEASE CONTACT:
Alex Blanchard, Communications Manager
NetworkNewsWire (NNW)
FORWARD-LOOKING STATEMENTS
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
Last updated: Apr 17, 2018