HEMP SponsorOne company is developing a medication for FDA approval that uses CBD to help people quit tobacco use.
With research into the potential benefits of cannabidiol (CBD) continuing on many fronts, innovative applications for CBD are being developed by companies around the world. One such firm is San Diego-based CV Sciences, which has recently made headway in the pursuit of using CBD to help with nicotine addiction.
CV Sciences is best known for its PlusCBD™ Oil line of full spectrum hemp CBD sprays, drops, capsules, topicals, soft gels, and gummies that are available across the country online and at brick-and-mortar retailers, including some CVS, Krogers and Sprouts locations. But the company also has a separate pharmaceutical division, which is currently working on a medication known for now as CVSI-007, to treat nicotine addiction and help people stop using smokeless tobacco products.
The patent-pending product, which has been in development for two years, combines synthetically produced CBD with nicotine, two compounds that can have similar effects on the body, according to Joseph Dowling, the CEO of CV Sciences.
“We decided to pursue this drug development program because there are certain mechanisms of action of CBD that we felt mimic what nicotine does in the body, except CBD is potentially stronger with a much greater half-life, so we believe the therapeutic range of a combination drug could be a very effective treatment for nicotine addiction,” said Dowling.
“And because of that,” he added, “the resulting therapeutic product could potentially treat nicotine addiction, rather than simply replacing one form of nicotine with another,” which is the strategy behind common nicotine replacement therapies such as Nicorette and NicoDerm.
Path to Approval Underway
CVSI-007, for which the company plans to seek U.S. Food and Drug Administration (“FDA”) approval as a prescription medication, is currently in preclinical development, undergoing extensive safety and toxicological analyses that are expected to be completed in the second half of this year. When ready for market, it could be offered in a dosage form for buccal or sublingual delivery.
“We believe this is a novel approach to really address the addiction as opposed to just replacing one form of nicotine for another,” said Dowling.
CV Sciences is hoping to earn FDA approval of the drug as treatment for smokeless tobacco cessation, a massive unmet medical need with no current FDA approved drug. The path to FDA approval is continuing, with human trials contemplated in Europe as soon as the fourth quarter of 2019 or early 2020. Dowling said the company is also planning to file an investigational new drug application with the FDA, sometime during the first half of 2020. An eventual launch date for CVSI-007 has not yet been determined.
“It’s really difficult to estimate a timeline to FDA approval,” Dowling said.
In addition to its drug to treat nicotine addiction, CV Sciences’ pharmaceuticals division is also working on other CBD-based medications, although no specifics have yet been announced. Dowling noted that CBD has been reported to be a potential therapy for other forms of addiction and post-traumatic stress disorder.
“Hemp is a very bioactive plant and we are just beginning to understand its therapeutic potential,” we believe there is tremendous promise that goes outside of nicotine addiction,” said Dowling.
This post is sponsored by CV Sciences. Thank you for supporting the businesses that have partnered with HEMP.
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