22nd Century’s Very Low Nicotine Cigarettes Significantly Reduce Withdrawal & Craving Symptoms in Vulnerable Population Gro...
October 20 2016 - 9:45AM
Business Wire
“When nicotine content is set very low…
dependence decreases, smoking rates decrease, and people are better
able to quit if they choose to do so.” – Dr. Stephen T.
Higgins, University of Vermont Center on Tobacco Regulatory
Science
22nd Century Group, Inc. (NYSE MKT:XXII), a leader in tobacco
harm reduction, announced today that scientists from the University
of Vermont Center on Tobacco Regulatory Science, Brown University,
Johns Hopkins University, and Southern Illinois University
published online in the October 2016 issue of Psychopharmacology a
new independent clinical study which concluded that, even among
vulnerable populations, 22nd Century’s Very Low Nicotine tobacco
cigarettes significantly reduce nicotine withdrawal and craving
symptoms. Dr. Stephen T. Higgins, et al., conducted the study,
which examined the effects of Very Low Nicotine cigarettes on
economically disadvantaged women, opioid-dependent individuals, and
individuals with affective disorders.
The FDA Center for Tobacco Products (CTP) partners with other
public health agencies to conduct research that drives tobacco
regulatory action based on the best available science. At the onset
of his clinical study, Dr. Higgins discussed the objectives for his
trial in an FDA sponsored Tobacco Regulatory Science in Action
video. In the video, Dr. Higgins explains that “when nicotine
content is set very low… dependence decreases, smoking rates
decrease, and people are better able to quit if they choose to do
so.” Characterizing the results of previous trials with Very Low
Nicotine cigarettes as “promising,” Dr. Higgins states clearly: “we
have to make cigarettes less addictive.”
The Higgins study, which exclusively used 22nd Century’s
SPECTRUM® research cigarettes as provided by the National institute
on Drug Abuse (NIDA), examined the potential impacts of enacting a
national policy to lower the nicotine content of cigarettes to a
level not capable of sustaining addiction. The study scientists
note that “there is now an abundance of evidence that very low
nicotine content cigarettes provide smokers with significant relief
[from withdrawal symptoms].”
Fifteen scientific papers from independent clinical studies have
already demonstrated a host of desirable outcomes for the broader
U.S. smoking population, including: reduced smoking, reduced
nicotine exposure, reduced nicotine dependence, increased
abstinence, reduced exposure to toxicants and few adverse events
with little evidence of withdrawal-related discomfort or safety
concerns. Independent scientists widely agree that 22nd Century’s
proprietary Very Low Nicotine cigarettes drastically reduce
smokers’ exposure to nicotine and do not result in compensatory
smoking. In contrast, “light” cigarettes (as previously labeled and
marketed by “Big Tobacco” companies like Altria Group, Inc. (NYSE:
MO) and Reynolds American, Inc. (NYSE: RAI)), merely reduce
machine-smoking nicotine yields by diluting the smoke rather than
by reducing the nicotine content of the tobacco itself.
Accordingly, “light” cigarettes made by Big Tobacco companies can
result in compensatory smoking and actually lead to increased
exposure to toxicants.
The paper by Dr. Higgins, et al. adds to the substantial number
of previous clinical trials that support the use of 22nd Century’s
Very Low Nicotine cigarettes with a nicotine content of 0.4mg/g.
Dr. Higgins reports that this 95-97% reduction in nicotine versus
conventional tobacco has “the greatest likelihood” of falling below
a nicotine dependence threshold. Only 22nd Century can grow tobacco
plants with such minute nicotine content.
“22nd Century’s Very Low Nicotine cigarettes have proven
beneficial for every examined smoker population, from the broad
U.S. smoking population to subsets that include smokers suffering
from schizophrenia, heavy consumers of alcohol, and now even the
most vulnerable groups among us,” noted Henry Sicignano, III,
President and Chief Executive Officer at 22nd Century Group. “Under
the Tobacco Control Act of 2009, the FDA has the regulatory
authority to mandate that all U.S. cigarette manufacturers offer
Very Low Nicotine brand styles so that smokers can have a
non-addictive choice. I understand why Altria might be hesitant to
embrace the idea of Very Low Nicotine Marlboro® cigarettes… but I
can no longer imagine why public health officials would
hesitate.”
About 22nd Century Group, Inc.
22nd Century is a plant biotechnology company focused on
technology which allows it to increase or decrease the level of
nicotine in tobacco plants and the level of cannabinoids in
cannabis plants through genetic engineering and plant breeding. The
Company’s primary mission is to reduce the harm caused by smoking.
22nd Century currently owns or exclusively controls more than 200
issued patents and more than 50 pending patent applications around
the world. Visit www.xxiicentury.com for more information.
Cautionary Note Regarding Forward-Looking Statements: This press
release contains forward-looking information, including all
statements that are not statements of historical fact regarding the
intent, belief or current expectations of 22nd Century Group, Inc.,
its directors or its officers with respect to the contents of this
press release, including but not limited to our future revenue
expectations. The words “may,” “would,” “will,” “expect,”
“estimate,” “anticipate,” “believe,” “intend” and similar
expressions and variations thereof are intended to identify
forward-looking statements. We cannot guarantee future results,
levels of activity or performance. You should not place undue
reliance on these forward-looking statements, which speak only as
of the date that they were made. These cautionary statements should
be considered with any written or oral forward-looking statements
that we may issue in the future. Except as required by applicable
law, including the securities laws of the United States, we do not
intend to update any of the forward-looking statements to conform
these statements to reflect actual results, later events or
circumstances, or to reflect the occurrence of unanticipated
events. You should carefully review and consider the various
disclosures made by us in our annual report on Form 10-K for the
fiscal year ended December 31, 2015, filed on February 18, 2016,
including the section entitled “Risk Factors,” and our other
reports filed with the U.S Securities and Exchange Commission which
attempt to advise interested parties of the risks and factors that
may affect our business, financial condition, results of operation
and cash flows. If one or more of these risks or uncertainties
materialize, or if the underlying assumptions prove incorrect, our
actual results may vary materially from those expected or
projected.
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version on businesswire.com: http://www.businesswire.com/news/home/20161020005415/en/
Investor Relations:IRTH CommunicationsAndrew Haag,
866-976-4784xxii@irthcommunications.comorRedington, Inc.Tom
Redington, 203-222-7399
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