Every day, the uses for cannabidiol, better known as CBD, continue to grow. A search of recent headlines shows CBD being employed in the treatment of Alzheimer’s, anxiety, and anti-aging skin products, to name but a few.
CV Sciences, a San Diego-based company previously known for utilizing the non-psychoactive cannabinoid in nutritional supplements and beauty products, is attempting to expand CBD’s value even further as it works to secure the Food and Drug Administration’s approval for its newest product: a CBD-nicotine hybrid gum to treat addiction to tobacco.
While the drug’s efficacy has equal promise for those who smoke, dip, or chew, CV Sciences is targeting those addicted to smokeless tobacco. Part of that decision is business — Dowling says “no one” could achieve patent protection for a product designed to treat nicotine addiction across the entire market — but part of it is a reflection of a lack of cessation drugs targeted toward smokeless tobacco users.
“The treatment market for treating and supporting cessation of smokeless tobacco use and addiction is currently, we believe, $2 billion,” Dowling says. “There’s not one single FDA-approved drug to treat that medical indication. Not a single one.”
Dowling also notes the rise of smokeless tobacco use among primarily 13- to 17-year-old boys, a trend that has lead the Center for Disease Control to label the situation an “epidemic.”
“There’s a tremendous need for safe and effective products that can help people with this problem and addiction,” Dowling explains.
At present, there are only two FDA-approved medications on the market to treat nicotine addiction. One is Pfizer’s Chantix, and the other is GSK’s Zyban. Both are prescription medications that carry what is known as “black box warnings,” which the FDA reserves for drugs that carry the most significant risks.
The FDA determined that suicidal behavior is a side effect of both Chantix and Zyban, and, according to a 2013 Al-Jazeera report, Chantix has been linked to over 500 suicides occurring between 2006 and 2013.
While the CBD-nicotine gum that CV Sciences is developing is a few years away from potentially reaching shelves, the science behind the drug is an encouraging examination of the ways in which CBD may ultimately inform the future of pharmaceuticals. CBD derived from industrial hemp or created in a synthesized form is legal in the U.S., and is already employed in drugs like Dronabinol, approved by the FDA for treatment of nausea, appetite issues, and for pain relief for patients with cancer, AIDS, and multiple sclerosis.
Dowling notes that, until now, CBD has been primarily used either in treatment of relatively rare conditions, like epilepsy, which according to the CDC affects about 1 percent of the U.S. adult population, or in attempts to revitalize orphan drugs (commercially undeveloped products lacking potential for profitability). CV Sciences wanted to find an opportunity that could both improve patient outcomes and make financial sense for the company. CV Sciences found it with the nicotine-addiction market.
“[Nicotine-addiction treatment drugs are] a very, very big market,” he says. “We believe the treatment market today is at least $2 billion, and we think it’s increasing to as much as $4 billion in the next five years.”
CV Sciences will ideally enter that market in two to three years with its proprietary CBD-nicotine gum, a product that Dowling believes has the potential to be a “very big drug” — one built entirely around the idea of CBD as a cessation aid for nicotine addiction.
Dowling explains that when consumed, nicotine acts as a mild antidepressant by functioning as an MAO-inhibitor that prevents “feel good” neurotransmitters from receding back into the brain’s chemistry. While nicotine has a half-life of one hour — thus forcing users to re-dose hourly to continue to feel its full effects — CBD has a half-life of 20 to 24 hours. CBD is also 10 times more powerful as an MAO-inhibitor, meaning that if utilized in a program, as one might with Nicorette gum, users could gradually lessen their nicotine intake while still enjoying the antidepressant effects they’ve come to depend on.
Based on the FDA’s preference for synthetic forms of chemical entities, CV Sciences is utilizing synthetic CBD in its gum product. Acknowledging the public perception that plant-based CBD is preferable to a synthetic alternative, Dowling refers to the scientific reality that there is no difference between plant-based and synthesized CBD.
Elaborating on the FDA’s predilection for synthesized chemicals, Dowling brings up a myriad of factors that can affect plant-based chemicals and thus make them unsuitable for usage in pharmaceutical drugs.
“Synthetic drugs can be controlled. They can be scaled,” he says. “If you’re growing indoor CBD, it’s very expensive, and it’s variable. If you grow it outside, the elements are a factor. Annual harvests have high variability because you’re dealing with birds, with pesticides and herbicides, and with natural metals that are in the Earth’s core that get into every plant we eat.”
While perhaps beyond the scope of CV Sciences’ aims, the truth of the matter is that CBD may prove to be a viable warrior in the fight against nicotine addiction across the spectrum. Science continues to find new and enticing uses for cannabinoid that has long suffered from the stigma of its cousin compound THC. Dowling agrees that while measures to legalize recreational marijuana use won’t directly affect his company’s work, it could go a long way toward altering public perception.
“I think these laws will create greater visibility for a misunderstood plant and the potential benefit from that plant to help people,” he says.