SANTA MONICA, CA / ACCESSWIRE / October 17, 2017 / According to the Centers for Disease Control and Prevention, tobacco use causes almost six million deaths annually, with that number expected to climb to eight million by 2030 based on current trends. In the U.S. alone, about one in five deaths, or approximately 1,300 deaths every day, are the result of cigarette smoking, making it a leading cause of preventable death.
Education has helped, but it is not enough by itself. Traditional drug makers have been bedeviled by the missed opportunity of treating nicotine addiction. Drugs like Pfizer’s Chantix (varenicline) and GlaxoSmithKline’s Zyban (Wellbutrin, bupropion) provide relief to some people, but for others, they can, quite literally, be a nightmare. While these drugs are approved for cigarette smokers and sometimes used off-label, there is no FDA-approved treatment for smokeless tobacco.
As scientists carry on with the quest for innovation in the anti-nicotine space, some are looking to cannabidiol (CBD), one of the more than 113 cannabinoids found in the cannabis plant that is known to have a litany of medical benefits. CBD is not to be confused with tetrahydrocannabinol (THC), the cannabinoid responsible for the intoxicating “high” associated with marijuana.
To understand why companies like CV Sciences (OTCQB: CVSI) are investigating the potential of CBD as a nicotine cessation tool takes at least a brief understanding of how nicotine works in the body. With every drag off a cigarette or putting chewing tobacco in the mouth, nicotine gets absorbed into the bloodstream where, amongst other things, it stimulates the brain to release dopamine, a neurotransmitter associated with a happy feeling resulting from its role in helping control the brain’s reward and pleasure centers. Other neurotransmitters, or brain chemicals, such as acetylcholine and glutamate, are released as well, giving nicotine users a burst of energy and good feeling.
However, the body eventually builds up tolerance for nicotine. Tolerance combined with the fact that nicotine has a half-life of only 1-2 hours in the body (e.g. effect is rapid and short-lasting), leads to people needing to absorb nicotine more frequently to get the same effect.
Against the backdrop of a seminal change ongoing with respect to legal cannabis, CBD could be a simple and creative way to address nicotine addiction, given the multiple pathways where the two intersect. This is not just anecdotal, as some earlier research supports the thesis that CBD can provide a meaningful benefit to help people kick their physical and mental nicotine dependence, while other research recently points to CBD potentially helping with different types of addiction.
Covering both biotech and the consumer products spaces, CV Sciences knows CBD. The company is engaged in the development, manufacturing, marketing and distribution of consumer products containing plant-based CBD, which is refined into its portfolio brands, Plus CBD Oil and Purified Liquids. The biotech unit is working to advance CVSI-007, an asset acquired in early 2016 through CV Sciences’ buyout of CanX and its subsidiary Canabine. CVSI-007 is a synthetically-formulated cannabidiol-based medicine in development as for smokeless tobacco cessation.
The plan is to formulate CVSI-007 for oral delivery as a chewing gum for clinical research, although any similar type of oral mucosal deliver (as a lozenge, for example) could be possible in the future should research warrant.
As the active pharmaceutical ingredient in a drug, CBD can work through multiple mechanisms of action to tackle addiction. The treatment of addiction is no less complex as the disease itself, with pathways setting off a cascading effect throughout the body that are not 100 percent understood. For its part, CBD can act upon the CB1 receptor, found predominantly in the brain and nervous system as part of the endocannabinoid system, which is integral to emotional memory processing, including emotional rewards associated with nicotine. Further, just like nicotine, CBD is an inhibitor of monoamine oxidase (MAO) in the brain. This means that CBD can regulate anxiety and depressive symptoms. This is aligned with the anti-depressant drugs Chantix and Wellbutrin being used as smoking cessation products.
Nicotine serving as an MAO inhibitor – and all that comes along with that including other signaling and intertwined cell pathways – dovetails with the pleasurable feeling associated with tobacco use. As mentioned, though, nicotine exits the body relatively expeditiously with a half-life of only up to two hours. CBD has a completely different pharmacokinetic profile, with a half-life of 24-36 hours. Considering the strong safety profile of CBD, the extra time in the body is a benefit to the user to ward off the negative effects of nicotine withdrawal while patients are titrated down.
In June, CV Sciences completed a pre-IND meeting with the U.S. Food and Drug Administration to review its clinical drug development plan of CVSI-007 for smokeless tobacco addiction. The company plans to follow a FDA 505(b)(2) pathway, which means that development can be hastened by leveraging the known safety data of nicotine-polacrilex gum, a nicotine replacement therapy already approved by the FDA, and the fact that the agency doesn’t consider CBD to be a new chemical entity.
A phase 1 study is expected to be initiated next year.
Oft-overlooked CV Sciences certainly doesn’t get mentioned in the same breath as bigger peers like GW Pharma, Zynerba Pharma or Insys Therapeutics. However, given the scale of the market opportunity people are likely to stand up and take notice should they be right that combining their proprietary product with nicotine-polacrilex gum could safely provide a meaningful cessation benefit for the hundreds of millions of nicotine consumers worldwide – or even just the nine million in the U.S. for that matter.
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