In the Weeds: Cannabis Clinical Trial Expands, Topicals Often Mislabeled, High Potency May Mean High Addiction

July 27, 2022
Newsworthy Highlights

Company to Expand Clinical Trial of Cannabis Therapy for Tourette Syndrome. A pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system recently announced it has started the process of preparing an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) for its Phase IIb clinical trial cannabis-derived product designed to treat patients suffering from Tourette syndrome (TS). The work toward an IND submission may facilitate the opening of a new U.S. site that will participate in the Phase IIb trial.

The product is being developed under the accelerated regulatory path of a Section 505(b)(2) application focused on augmenting FDA-approved natural and synthetic cannabinoids to create therapies that potentiate the effects of cannabinoids and target the receptors implicated in modulating the central nervous system.

After a successful Phase IIa trial, with the reduction of tic symptoms in TS patients of about 21% across the sample, the company is proceeding to the next phase in the clinical trial process. The primary efficacy objective of the trial will be to assess tic severity change using the most commonly used measure in clinical trials, as a continuous endpoint at week 12 and week 26 of the double-blind phase. The primary safety objective of the trial will be to assess absolute and relative frequencies of serious adverse events for the entire population and separately for the drug candidate and placebo groups.

Study Finds Mislabeling a Common Issue in Topical Cannabinoid Products. A recent study found frequent mislabeling of retail topical cannabis products (e.g. lotions, creams and patches). This study is consistent with several others that recently highlighted concerns regarding mislabeling of cannabinoid products.

The study evaluated 105 topical cannabinoid products, finding that 18% were overlabeled (containing over 10% less CBD than advertised) and 58% were underlabeled (containing over 10% more CBD than advertised). Only 24% of products were accurately labeled. Of the evaluated products, 35% contained THC, though all contained less than 0.3% THC. Of note, only 47% of products noted that they were not FDA-approved.

The study authors noted that “these findings suggest that improved regulatory oversight of cannabis and hemp products is needed to ensure quality assurance, deter misleading health claims, and potentially prevent unwanted drug effects among consumers…. [C]linical studies are needed to determine whether topical cannabinoid products with THC can produce psychoactive effects or positive drug tests for cannabis.”

High Potency Means Highly Addicting? New Literature Review Suggests the Possibility. New research by a team of European researchers was published July 25, 2022, in The Lancet of Psychiatry. Prominent cannabis researcher Tom Freeman at University of Bath and colleagues found preliminary evidence to suggest that higher potency of delta-9 tetrahydrocannabinol (THC) may be associated with increased risk of developing psychosis and cannabis use disorder, an addiction disease. The team screened more than 4171 articles for evidence of milligrams of delta-9 THC potency and symptoms of psychosis and cannabis use disorder, concluding a correlation was present based on literature review. This is one of the largest and most significant literature reviews of patient data to date. While the evidence is far from voluminous, more studies are showing a link between psychological disorders and THC dosage in marijuana products.

Washington, D.C., Will Protect Employees Who Use Recreational Cannabis. Although currently unfunded, the Cannabis Employment Protections Amendment Act of 2022 will prohibit employers from taking adverse action against employees or applicants based on their use of cannabis, their status as a medical cannabis program patient, or their failed marijuana drug test without additional indicia of impairment. For details, see this July 20, 2022, McGuireWoods alert.

Grassroots Federal/State Legislative Highlights

NY Cannabis Board Approves Rules for Marijuana Retail Licenses and Applicants. The New York State Cannabis Control Board unanimously approved and finalized its proposed regulations for state-issued retail dispensary licenses.

The regulations are intended to advance New York’s social equity efforts and will allow entrepreneurs, or family members of entrepreneurs, who have been convicted of a marijuana-related crime (as defined in the regulations) before marijuana was legalized in the state, to be the first to apply for retail dispensary licenses. Recent articles stated that the board is committed to providing “justice-involved individuals” the first opportunities in the marijuana industry as they have been the most affected by state and federal drug laws, which have disproportionately targeted certain neighborhoods and communities of color.

Applicants can apply for dispensary licenses through the Office of Cannabis Management, which expects to give out between 100 and 200 licenses. Big marijuana retailers in other states must wait until the board implements further regulations and likely will have to compete for licenses to operate their businesses in New York.

Illinois Issues Conditional Adult Use Dispensing Licenses. On July 22, 2022, Illinois published its first list of conditional adult use dispensary licenses in the Naperville-Chicago-Elgin BLS Region. The next set of licenses will be announced on or before Aug. 5, 2022. The conditional license does not authorize cannabis sales. It is the beginning of the 180-day period to build out the dispensary and subsequently receive approval to operate. Applicants also will need to obtain and submit documentation showing zoning approval, in addition to a written consent statement from the property landlord. Once build-outs are complete, the location will be inspected to ensure compliance.

Vermont Notifies Agriculture Department of Hemp Production Plan Withdrawal. The Vermont Agency of Agriculture, Food & Markets notified the U.S. Department of Agriculture (USDA) that it will end its USDA-approved hemp production plan effective Dec. 31, 2022. Beginning in 2023, hemp growers will need to register under USDA’s grower licensing system. According to the withdrawal letter, the state will work with USDA to coordinate a smooth transition.

Transaction Highlights

Global Cannabis Company Acquires Hempirical Genetics. Weed Inc., a global cannabis company focusing on hemp bioresearch and the development and use of various cannabis-derived compounds for treatment of both human and animal diseases, acquired Hempirical Genetics for 2 million shares of common stock valued at 25 cents per share and $250,000 in cash over four years, according to the press release.

Also according to the press announcement, Weed Inc. now has more than 15 “pure” original cannabis strains and 30 CBD and CBG strains. Weed Inc. believes these strains will be influential in proceeding with clinical trials and product development to achieve the company’s desired medical outcomes. As cannabis legislation continues to provide more protections for the plant’s use, Weed Inc. plans to eventually bring these strains to the recreational cannabis market as well.

Weed Inc.’s CEO stated that the purpose of the acquisition was to provide “double the quality, half the price…, while creating diversity and equality to the cannabis sector.”

“In the Weeds” is McGuireWoods’ biweekly ounce of highlights in the budding cannabis, hemp and CBD industries. For more information, see our newsletter archive, our Edible Bites podcast series (available on Apple and Spotify), or visit our Cannabis, Hemp & CBD practice.