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Editorial Coverage: Most people who try to quit smoking
cigarettes will fail. Why? Scientific research shows that the
overwhelming culprit is nicotine. Nicotine holds such an addictive
power over smokers, because it arrives in the brain so quickly —
smoking delivers nicotine even faster than an injection, one
researcher notes (http://nnw.fm/uunO1). While people know that smoking
is a preventable killer, they also know that quitting is far easier
said than done. Nicotine replacement therapy (NRT) products such as
nicotine gums, lozenges, sprays, sublingual tablets and transdermal
patches dominate the multibillion-dollar global smoking cessation
and nicotine de-addiction market. However, all commercial forms of
NRT have different levels of efficacy and variable rates of
nicotine absorption, as noted in an article published by the
National Institutes of Health (http://nnw.fm/BgcC7). Enter drug delivery platform
innovator Lexaria Bioscience Corp. (CSE: LXX)
(OTCQX: LXRP)
(LXRP
Profile), which recently announced a
significant breakthrough in alternative nicotine delivery
technology that was first proven effective in cannabinoid or CBD
delivery. Other biotechnology companies conducting research in
similar arenas include GW Pharmaceuticals Plc
(NASDAQ: GWPH), CV
Sciences, Inc. (OTCQB: CVSI), 22nd Century Group,
Inc. (NYSE American: XXII) and
Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE).
Research Goals Beyond CBD
The latest research results announced by Lexaria
Bioscience Corp. (CSE: LXX) (OTCQX: LXRP) are
significant for a host of reasons and could have ramifications for
other drug delivery methods as well. In this specific study,
Lexaria’s patented DehydraTECH™ delivery technology was analyzed
for use as a new nicotine delivery method. The company’s
proprietary technology improves the delivery of bioactive compounds
and has already shown to enhance the bioavailability of orally
ingested cannabinoids (CBDs) derived from cannabis, while also
masking taste. Third-party labs have shown a 499 percent increase
in CBD bio-absorption in human intestinal tissues, as the company
noted in a news release announcing a U.S. patent for DehydraTECH™
(http://nnw.fm/2WP8e). As such, it made sense to
further analyze DehydraTECH’s capabilities in terms of nicotine
delivery.
Gathering Clinical Evidence
Lexaria’s study hypothesis was tested to prove that its
DehydraTECH technology would influence more rapid and complete
intestinal bioabsorption of ingestible (edible) nicotine
lymphatically with less metabolic degradation by the liver. The
study, conducted by the same independent laboratory that completed
Lexaria’s initial cannabidiol absorption study in 2016, rendered
positive topline results.
Lexaria’s ingestible nicotine study using DehydraTECH delivered
nicotine to the bloodstream within 15 minutes, provided an
increased gain of 148 percent of peak nicotine to the bloodstream
and produced 560 percent higher brain levels of nicotine, where the
nicotine’s effects are focused. Lower urine levels of nicotine were
also noted, signifying enhanced nicotine activity and
bioavailability, and lower quantities of key liver metabolites were
found in the bloodstream, suggesting bypass of first liver
metabolism. Together, these findings suggest a prolongation of
nicotine effectiveness with the Lexaria formulation, which may also
be beneficial in controlling cravings over an extended time period
from a single edible nicotine dose.
All of this is good news for Lexaria and its proprietary
technology. The findings also prompt the question of whether the
technology could be used to help reduce unwanted side effects
common to many other drugs. Ibuprofen, for instance, can cause
uncontrolled gastric bleeding and issues relating to liver and
kidney disease. While further analysis and testing is required,
Lexaria President John Docherty said that researchers are intrigued
with the nicotine study results.
“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 DehydraTECH technology than controls,” Docherty
said in the news release announcing the results. “This data
supports further investigation of the many possible benefits of our
DehydraTECH 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.”
Does Nicotine Have a Bad Rap?
Vanderbilt University Medical Center (VUMC) is one of 29 sites
participating in a national study funded by the National Institute
on Aging to determine whether a daily transdermal nicotine patch
will have a positive effect on attention and early memory
impairment in older adults diagnosed with mild cognitive impairment
(MCI). More than eight million Americans are currently diagnosed
with MCI, a condition that affects memory or other thinking skills.
Recent evidence shows that adults with MCI are at a higher risk for
subsequently developing Alzheimer’s disease.
FDA Commissioner Dr. Scott Gottlieb has said that “the
overwhelming amount of the death and disease attributable to
tobacco is caused by addiction to cigarettes. Addiction causes
long-term sustained use. But it’s exposure to the harmful chemicals
[from combustion] that causes disease (http://nnw.fm/r7Yo0).”
Paul Newhouse, M.D., director of the Center for Cognitive
Medicine at VUMC and national director of the study, said that
nicotine, a natural plant alkaloid, is a fascinating drug with
interesting properties. “People think of it as a potentially
noxious substance, but it’s a plant-derived medication just like a
lot of other medications,” Newhouse stated in an article published
by Vanderbilt University (http://nnw.fm/lZf5f).
Global Goals
The worldwide smoking cessation and nicotine de-addiction market
is expected to reach over US$21.8 billion by 2024, according to a
report by Grand View Research, Inc. (http://nnw.fm/zpF9t). The increasing desire to quit
smoking and the numerous health complications associated with
smoking serve as strong incentives for companies to introduce novel
smoking cessation products, the report states.
Lexaria plans to partner, not compete, with tobacco companies
that are also seeking new ways to reduce the known hazards of
smoking and comply with upcoming Food and Drug Administration
regulations. Lexaria has entered into third-party licensing
agreements within the cannabis industry, and it seeks to do the
same within the tobacco industry.
And according to Euromonitor International and British American
Tobacco, p.l.c., the global nictotine/tobacco market is US$980
billion per year: Lexaria’s technology could also find great
applicability as a potential long-term alternative form of nicotine
delivery to replace combusted forms. The world’s top tobacco
companies may be in trouble: Phillip Morris lost $20 billion in
market cap in a single day on April 19 after revenue results for
one of its noncombusted delivery products disappointed the market.
Frankly, the tobacco industry may be looking for new technology
like Lexaria offers to preserve their massive businesses.
Lexaria’s DehydraTECH provides a complementary layer suitable
for a versatile range of commercial applications, allowing for a
potentially healthier alternative to smoking or vaping practices
for both cannabis and nicotine users. With more than 35 patents
pending in over 40 countries, Lexaria is the only company in the
world with a patent in the United States and Australia for the
improved (oral or ingestible) delivery of all nonpsychoactive
cannabinoids. And Lexaria’s technology is already patent granted in
the US for delivery of nicotine.
Making a Difference
Lexaria’s pointedly focused research is devoted to understanding
the human endocannabinoid system and how it can function at a
higher level through the efficient and healthy ingestion of
cannabinoids, but its research efforts are compatible with a wide
range of consumer-related compounds. Bioavailability matters a lot,
as all biotechnology companies are aware. Higher bioavailability is
often associated with lower overall doses of certain molecules,
which can be related to reduced stress on the liver and other
organs. In addition, it may also generate cost savings for
consumers.
Working solely in the field of plant-derived cannabinoid
therapeutics, GW Pharmaceuticals Plc
(NASDAQ: GWPH) has developed the
world’s first prescription medicine derived from the cannabis
plant. Sativex® is now approved in numerous countries outside of
the United States for the treatment of spasticity due to multiple
sclerosis. The company’s deep pipeline of additional clinical stage
cannabinoid product candidates is focused on neurological
conditions. Lead product candidates include Epidiolex®, which is
initially designed to treat rare and severe early-onset, drug
resistant epilepsy syndromes.
CV Sciences, Inc. (OTCQB: CVSI) operates in two
distinct divisions — pharmaceuticals and consumer products — with
both utilizing cannabidiol products. CV Sciences’ Pharmaceutical
Division is pursuing FDA approval for the development of
synthetically formulated cannabidiol-based medicines. The company’s
consumer division already distributes botanical-based cannabidiol
products nationally in health food stores, in the offices of health
care providers and online.
22nd Century Group, Inc. (NYSE American: XXII)
is a plant biotechnology company whose long-term focus is on
reducing the harm caused by smoking. The company’s proprietary
genetic engineering technology and plant breeding expertise results
in tobacco plants that have up to 97 percent less nicotine than
conventional tobacco, as well as plants with relatively high
nicotine levels. The applications for this technology include a
very low nicotine tobacco that can be used in smoking cessation aid
products and a tobacco with a low tar-to-nicotine ratio for those
who do not want to quit smoking but want to ingest less of the
known harmful byproducts of tobacco products.
Zynerba Pharmaceuticals Inc. (NASDAQ:
ZYNE) is dedicated to the development and
commercialization of innovative transdermal pharmaceutically
produced cannabinoid treatments for rare and near-rare
neuropsychiatric conditions in patients with high, unmet medical
needs. Zynerba’s ZYN002 CBD gel is the first and only
pharmaceutically produced CBD formulated as a patent-protected
permeation-enhanced transdermal gel. It is being studied in
children and adolescents with Fragile X syndrome and developmental
and epileptic encephalopathies, as well as in adult epilepsy
patients with facial seizures.
Healthier Options
Cigarette smoking remains the leading cause of preventable
disease and death in the United States, according to the Centers
for Disease Control (http://nnw.fm/aC6IZ). The launch of improved and
innovative nicotine replacement therapy products is expected to
make a significant impact on this multibillion-dollar market as
more people around the globe become increasingly aware of the
health hazards tied to smoking.
For more information on Lexaria, please visit Lexaria
Bioscience Corp. (CSE: LXX) (OTCQX: LXRP).
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