Company Developing Prescription CBD for Smokeless Tobacco Addiction
LAS VEGAS, NV – (Marketwired – July 5, 2017) – CV Sciences, Inc. (OTCQB: CVSI) (the “Company,” “CV Sciences,” “our” or “we”), today provided an update on published outcomes of recent clinical research on pharmaceutical-grade cannabidiol (CBD) pointing to its therapeutic potential as a prescription drug.
In The New England Journal of Medicine published on May 25, 2017, a clinical trial of pharmaceutical-grade CBD as an adjunct to standard anticonvulsive therapy sponsored by GW Pharmaceuticals in the control of a rare unremitting, drug-resistant seizure disorder, Dravet’s syndrome, demonstrated a statistically significant reduction in the number of seizures in the patients receiving CBD versus placebo while both groups were maintained on standard anticonvulsants. A total of 120 children and young adults were randomly assigned to receive either CBD in an oral solution at a dose of 20 mg/kg or placebo and then followed for 14 weeks. The control group had a median change from baseline of 14.9 convulsive seizures per month to 14.1 whereas the CBD-treated group had a median change from baseline of 12.4 convulsive seizures to 5.9 per month (P<0.01). It seems then that CBD may be a useful adjunct to anticonvulsive medication in this syndrome.
Currently, there are no FDA-approved indications for CBD. The scientific basis for CBD’s potential as a prescription treatment for diseases such as seizure disorders, schizophrenia, depression, anxiety, autoimmunity, drug addiction, and pain is suggested principally by in vitro and animal models of evidence of activity, but well-controlled human clinical trials are needed for substantiation of its anticipated therapeutic benefits.
Fortunately, pharmaceutical development companies are now pursuing diverse indications for pharmaceutical-grade CBD. The quality of human studies supported by these corporate sponsors is improving the confidence in clinical research on CBD significantly. In the past, albeit important contributors to the development of CBD, most clinical CBD studies were conducted by academic centers, typically using non-pharmaceutical-grade botanical CBD formulations with limited numbers of patients and limited trial designs, but more recent clinical studies are being conducted under corporately sponsored Investigational New Drug (IND) protocols sanctioned by the FDA using pharmaceutical-grade CBD in multicenter, randomized, double-blinded, parallel group trials with robust outcomes. These studies are beginning to provide meaningful support for the therapeutic benefits of CBD as a prescription drug.
CV Sciences, Inc. is devoted to the pioneering development of a prescription synthetic CBD as an adjunct to nicotine-replacement therapy (NRT) in the treatment of smokeless tobacco (ST) addiction. There is no approved therapy for smokeless tobacco addiction. Prior attempts to use NRT, for example, have failed in achieving abstinence for ST addiction. CV Sciences believes that its patent-pending approach to adjunctive use of CBD with NRT will be successful in achieving abstinence from ST based on CBD’s effects on the molecular targets that are known to play a role in nicotine dependence. According to Statista, there was approximately $5.3 billion in retail sales of smokeless tobacco products in 2014 and approximately 1.3 billion units of smokeless tobacco products sold during that time. CV Sciences believes that its initial drug candidate to treat smokeless tobacco addiction can dramatically improve patient outcomes for millions. Currently the smokeless tobacco cessation market is estimated at $2 billion, growing to over $4 billion.
About CV Sciences, Inc.
CV Sciences, Inc. (OTCQB: CVSI) operates two distinct business segments: a drug development division focused on developing and commercializing novel therapeutics utilizing synthetic CBD; and a consumer product division in manufacturing, marketing and selling plant-based CBD products to a range of market sectors. CV Sciences, Inc. has primary offices and facilities in San Diego, California and Las Vegas, Nevada. Additional information is available from OTCMarkets.com or by visiting www.cvsciences.com.
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