CV Sciences, Inc. (OTCQB: CVSI) reports it first patent-pending drug product candidate, CVSI-007, combines CBD and nicotine in treatment of smokeless tobacco use and addiction. According to CV Sciences recent 10K filing there are currently no drugs approved by the U.S. Food & Drug Administration (“FDA”) for treatment of smokeless tobacco use and addiction.
The Company is hopeful to be in a position to file an Investigational New Drug Application (“IND”) with the FDA in the future and says it expects to hold a pre-IND meeting with the FDA during the first half of 2017 to obtain guidance on this development program.
Michael Mona, Jr., President and CEO of CV Sciences, said, “We strongly believe that highlighting these examples is critical as we at CV Sciences are addressing a massive unmet medical need in the treatment of smokeless tobacco addiction. Currently, there are no FDA-approved drugs to treat this widespread and deadly addiction. Our lead drug candidate, CVSI-007, is aimed at addressing this huge unmet need. We estimate that the current treatment market in the U.S. alone is greater than $2 billion.”
Competition in the industry is heating up with news that 22nd Century Group, another micro-cap public company, is also developing hemp based products to reduce the harm caused by tobacco.