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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