Charlotte Figi was a revolutionary figure in medical cannabis. Born with Dravet syndrome, a rare form of epilepsy, she suffered from seizures every 30 minutes—until her parents met with the Stanley brothers, siblings in Colorado who were breeding a medical cannabis strain with high levels of cannabidiol (CBD). Charlotte was their first patient. After she started treatment, her seizures significantly dropped off—and then stopped—transforming her life. The Stanley brothers honored their first patient by naming their company, Charlotte’s Web, after her.

Sadly, Charlotte succumbed to her syndrome in April. But Charlotte will forever serve as inspiration for the significant health, wellness, and medical potential of cannabis.

“She made me realize that it would not just be a medical failing, but a moral failing if this medicine was somehow withheld from people,” said Dr. Sanjay Gupta in his tribute to Charlotte after she passed. In 2013, the noted neurosurgeon reversed his perspective on medical cannabis after hearing her story.

For Charlotte and countless others dealing with epilepsy, cancer, Crohn’s disease, chronic pain, multiple sclerosis, Tourette’s syndrome, Parkinson’s disease, and many more syndromes, diseases, and conditions, cannabis is essential medicine. And the market for cannabis-infused foods and beverages shows significant potential for growth.


An Emerging Market

In April, BDSA (formerly BDS Analytics) reported that 2019 legal cannabis sales grew by 46 percent to $14.8 billion, the industry’s highest annual rate of growth to date. BDSA noted that part of this strong growth was due to medical programs in U.S. states that reported higher-than-expected sales in 2019, boosting overall U.S. growth.

But while medical cannabis research has likewise made significant strides over the past few years, this field is still in its infancy.

“The medical cannabis market is in its nascent stage in numerous countries,” says Wayne Nasby, COO, Tikva, Los Angeles. “The market is estimated to possess high growth potential due to increasing legalization demand. Research on cannabis’s potential for medical use is on an upsurge. Many companies in the U.S. will further drive investigational research on medical cannabis, thus propelling industry growth.”

As the cannabis industry exponentially expands, so will medical research, seeking to find pathways to improve human life. “Research on cannabis’s potential for medicinal use is on the rise,” says Nasby. “Government organizations and private companies are undertaking several initiatives to explore medical cannabis for relieving pain. Pain management is the largest application of medical cannabis, and research is aimed to reduce the overuse of opioids and combat the nationwide opioid addiction crisis.”

According to the U.S. National Library of Medicine and Prohibition Partners, 564 clinical trials are currently ongoing that involve cannabis, says Maribeth O’Connor, vice president, medical applications, SõRSE Technology, Seattle. “Of these 564 studies, 343 are located in the U.S., 106 in Europe, 49 in Canada, and 35 in the Middle East.” She notes that the amount of research has exploded over the past couple of years related to treating depression, cancer, multiple sclerosis, amyotrophic lateral sclerosis (ALS, commonly known as Lou Gehrig’s disease), and more. “These studies have real potential to improve patients’ lives.”

"Many companies in the U.S. will further drive investigational research on medical cannabis, thus propelling industry growth"

In 2018, FDA approved Epidiolex, a prescription oral solution from GW Pharmaceuticals made with CBD, which reduced seizure frequency from baseline by 30 to 40 percent in late-stage trials for patients with two rare forms of childhood-onset epilepsy, says Kristina Susser, senior vice president, medical group, SõRSE Technology. “Today, GW Pharmaceuticals is looking to expand Epidiolex’s label, and is working on new cannabinoid-based therapies for indications such as spasticity associated with multiple sclerosis and autism spectrum disorder.”

In April, GW Pharmaceuticals announced that the DEA has descheduled Epidiolex so that is no longer a controlled substance. Following FDA approval in 2018, Epidiolex was initially placed in Schedule V of the Controlled Substances Act (CSA), meaning that it has a very low potential for abuse and has a currently accepted medical use in treatment. Descheduling the CBD-infused medicine removes all federal controlled-substance restrictions for Epidiolex. This demonstrates a strong federal perspective on the medical potential of CBD-based treatments.


Formulation Insights

Today’s medical cannabis market is not without its challenges. “There are no uniform regulations, standardization, and/or quality standards to safeguard the patient’s health,” says Nasby. “Irregularities and non-uniformity of cannabis testing standards is a significant concern. Medical cannabis quality testing laws vary from state to state, with some requiring only THC and CBD reporting. Products are not subjected to rigorous consumer safety testing and, therefore, patients are left with the burden of finding and sourcing the best and safest medical cannabis themselves. Contaminated medical cannabis is particularly risky for medical cannabis patients with compromised immune systems.”

Therefore, cannabis brands operating in the medical market must take extra steps to help ensure product safety and efficacy—and then clearly communicate those steps.

“Food safety should be any food and beverage company’s primary consideration when developing products for vulnerable medical customers,” says O’Connor. “For example, our emulsion uses common, well-established food ingredients that are understood by the market. On the safety side, we test for pesticide residue, heavy metals, mycotoxin growth, and bacterial growth. On the quality side, we generate a certificate of analysis (COA), a lab report which verifies the chemical makeup of the emulsion, which details its cannabinoid, terpene, and contaminant profile.”

Companies should have comprehensive risk analysis and food safety plans that are common in the food industry, says Susser. “This would ensure that they meet top quality standards every step of the way.” She notes that SõRSE only uses pharmaceutical-grade materials when making formulations for vulnerable populations.

Many current medical cannabis studies are honing in on the impact of cannabis on pain management, neurological/cognition/sleep, obesity and diabetes, and addiction, says Susser. SõRSE Technology is collaborating with Pascal Biosciences on cancer research—and specifically the effect of cannabinoids on the major histocompatibility complex (MHC) receptor, which allows the immune system to identify a cancer cell, resulting in the immune system performing at a more-effective level. “CBD forces the MHC receptor to go back onto a cancer cell so the cancer cell can be identified,” she says. The next step of the research will investigate how and why that works.

Susser notes that Pascal Biosciences has developed PAS-403, a mitosis inhibitor that blocks cell division. “The cannabinoid-based product is undergoing development for the treatment of glioblastoma and brain metastases originating from other cancers. Pascal’s work is showing that CBD is helping your own immune system identify dangerous cells like cancer in your body, which then allows your T-cells to identify and attack those cancer cells. The CBD is reattaching an identifier mechanism that allows the T-cells to perform the way they were designed to.”

The momentum behind the health, wellness, and medical potential of cannabis is increasing. “In the past two months, across the country we have seen a shift in the way the population and government officials view cannabis,” says Susser. “In mid-March, when many cities and states started enacting shelter-in-place orders, cannabis was deemed an essential business. This meant that both medical and recreational dispensaries would remain open and continue to serve their patients and customers. Because more cannabis users are trying edibles as opposed to buying flower, the outlook for medical cannabis food and beverage producers is highly positive.”

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