NEW YORK, September 27, 2016 /PRNewswire/ --
Despite all the advances we have made in the medical field,
overcoming addictions are still a challenge with an unmet need.
Nicotine remains the largest addiction problem in the world.
Consumers seem to be somewhat shifting from the traditional tobacco
cigarettes to smokeless tobacco. According to a research conducted
by Statista in 2014, U.S. convenience stores generated
approximately 5.31 billion U.S.
dollars from chewing tobacco and snuff products, which
represents approximately 1.26 billion units of smokeless tobacco
sold. CV Sciences, Inc. (OTCQB: CVSI), GlaxoSmithKline
plc (NYSE: GSK), Pfizer Inc. (NYSE: PFE), Zynerba
Pharmaceuticals Inc (NASDAQ: ZYNE), GW Pharmaceuticals
plc (NASDAQ: GWPH)
Nicotine addictions are hard to overcome, yet several companies
are innovating possible solutions. CV Sciences, Inc. (OTCQB:
CVSI) for example emphasizes synthetic Cannabidiol (CBD) and its
affects on nicotine addicts. CV Sciences, Inc. is a life science
company that focuses on two segments: pharmaceuticals and consumer
products. The pharma business segment is focused on development and
commercialization of therapeutics utilizing CBD, and the consumer
products segment is focused on manufacturing, marketing and selling
plant-based CBD products to a range of market sectors.
CV Sciences, Inc. (CVSI) main drug candidate,
CVSI-007, is a chewing gum that combines synthetic CBD with
nicotine, which according to the company has potential to treat
smokeless tobacco and tobacco addiction. The chewing gum meets the
three requirements for treatment of nicotine addiction. First, CBD
inhabits monoamine oxidase, providing antidepressant effects
replacing tobacco alkaloids. Second, doses of nicotine address
nicotine addiction and cravings. Third, since it's a chewing gum it
will provide oral stimulation for the addict.
In a recent letter to shareholders, CEO of CV Sciences,
Inc. (CVSI), Michael Mona
stated that, "Given that there are no FDA-approved drugs to treat
smokeless tobacco addiction and that the FDA has approved numerous
nicotine replacement therapy drugs (NRTs), we believe that our drug
candidate will be extremely well-received in the market. Also, the
FDA has recent drug development experience with CBD, which we
believe could accelerate the drug development process and
approval."
Some big pharma companies had manufactured non-CBD products for
smoking cessation, yet the FDA was quite explicit in its demands
regarding the marketing of their products. GlaxoSmithKline
plc (NYSE: GSK) for example, the maker of an FDA-approved
Bupropion based product called Zyban, had to redesign their
packages to place a black box warnings indicating potentially
serious mental health changes.
Pfizer Inc. (NYSE: PFE) has encountered with similar
problems with Chantix. A black box warning was required and in
June 2011 the FDA issued more safety
information regarding Chantix, claiming that it "may be associated
with a small, increased risk of certain cardiovascular adverse
events in patients who have cardiovascular disease." Pfizer is
required to add this warning label for Chantix.
Chantix has been a blockbuster drug for Pfizer, generating
$846 million revenue in 2008. Sales
have declined since then as the warning labels scared some
customers away, and yet with $672
million generated in 2015 Pfizer clearly successfully
capitalized on an unmet need. Cannabidiol might be the ingredient
needed to overcome the serious side affects associated with other
smoking cessation products.
CBD is being researched for a wide scope of potential
applications in part due to reports showing lack of side effects.
Zynerba Pharmaceuticals Inc (NASDAQ: ZYNE) for
example is developing synthetic cannabinoid therapeutics for
transdermal delivery for patients with high unmet medical needs,
including epilepsy, Fragile X syndrome, osteoarthritis,
fibromyalgia and peripheral neuropathic pain through these
therapeutics.
Then there is GW Pharmaceuticals plc (NASDAQ:
GWPH) a biopharmaceutical company focused on discovering,
developing and commercializing novel therapeutics from its
proprietary cannabinoid product platform. On September 26th the company announced
positive results of the second randomized, double-blind,
placebo-controlled Phase 3 clinical trial of its investigational
medicine Epidiolex® (CBD) for the treatment of seizures associated
with Lennox-Gastaut syndrome (LGS), a rare and severe form of
childhood-onset epilepsy.
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