Cannabis Clinical Trial Expands, Topicals Often Mislabeled, High Potency May Mean High Addiction

Cannabis Clinical

Company to Expand clinical test of Cannabis Therapy for Tourette Syndrome. A drug company focusing on developing therapies to treat disorders of the central nervous system recently announced it has started preparing an Investigational New Drug (IND) Application with the U.S.

Food and Drug Administration (FDA) for its Phase IIb clinical test cannabis-derived product designed to treat patients suffering from Tourette syndrome (TS).

The work toward an IND submission may facilitate opening a replacement U.S. site that will participate in the Phase IIb trial.

The product is being developed under the accelerated regulatory path of 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 corporate is proceeding to the next phase in the clinical trial process.

The first efficacy objective of the trial will be to assess tic severity change using the most commonly used measure in clinical trials as an endless endpoint at week 12 and week 26 of the double-blind phase.

The first 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 standard 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 according to several others that recently highlighted concerns regarding mislabeling cannabinoid products.

The study evaluated 105 topical cannabinoid products, finding that 18% were over-labeled (containing over 10% less CBD than advertised) and 58% were under-labeled (containing over 10% more CBD than advertised).

Only 24% of products were accurately labeled. Of the evaluated products, 35% contained THC, though all contained 0.3% THC. Of note, only 47% of products noted that they weren’t FDA-approved.

The authors noted that “these findings suggest that improved regulatory oversight of cannabis and hemp products is required to ensure quality assurance, deter misleading health claims, and potentially prevent unwanted drug effects among consumers.

Clinical 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 likelihood. New research by a team of European researchers was published on July 25, 2022, in the Lancet of Psychiatry.

Prominent cannabis researcher Tom Freeman at the University of Bath and colleagues found preliminary evidence to suggest that higher potency of delta-9 tetrahydrocannabinol (THC) could also be associated with an increased risk of psychosis and cannabis use disorder, an addiction disease.

Also read – Five Pet CBD Companies with Innovative Products.

The team screened 4171 articles for evidence of milligrams of delta-9 THC potency and symptoms of psychosis and cannabis use disorder, concluding a correlation was present, supported the literature review.

This is often one of the largest and most significant literature reviews of patient data. While the evidence is way from voluminous, more studies show 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 supported by their use of cannabis, their status as a medical cannabis program patient, or their failed marijuana drug test without additional indicia of impairment.

Grassroots Federal/State Legislative Highlights

NY Cannabis Board Approves Rules for Marijuana Retail Licenses and Applicants. The NY 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. They can allow entrepreneurs, or relations of entrepreneurs, who are convicted of a marijuana-related crime (as defined in the regulations) before marijuana was legalized in the state to be the primary to apply for retail dispensary licenses.

Recent articles stated that the board is committed to providing “justice-involved individuals” the primary 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 offer between 100 and 200 licenses. Big marijuana retailers in other states must wait until the board implements further regulations and certainly will have to compete for licenses to operate their businesses in New York.

Also read – Visit Mendocino County Taps Into $1.7 Billion U.S. Cannabis Tourism Niche.

Illinois Issues Conditional Adult Use Dispensing Licenses. On July 22, 2022, Illinois published its first list of conditional adult use dispensary licenses within the Naperville-Chicago-Elgin BLS Region.

The subsequent licenses will be announced on or before Aug. 5, 2022. The conditional license doesn’t authorize cannabis sales. It’s the beginning of the 180 days to build out the dispensary and subsequently receive approval to operate.

Applicants will also have to obtain and submit documentation showing zoning approval and a written consent statement from the property landlord. Once build-outs are complete, the situation will be inspected to ensure compliance.

Vermont Notifies Department of Agriculture of Hemp Production Plan Withdrawal. The Vermont Agency of Agriculture, Food & Markets notified the U.S. Department of Agriculture (USDA) that it’ll end its USDA-approved hemp production plan effective Dec. 31, 2022.

Beginning in 2023, hemp growers must register under USDA’s grower licensing system. Consistent with 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 worldwide cannabis company focusing on hemp bioresearch and the development and use of various cannabis-derived compounds for the treatment of both human and animal diseases, acquired Hempirical Genetics for two million shares of common stock valued at 25 cents per share and $250,000 in cash over four years, consistent with the press release.

Also read – Five Pet CBD Companies with Innovative Products.

Also consistent with the press announcement, Weed Inc. now has 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 supply more protections for the plant’s use, Weed Inc. plans to bring these strains to the recreational cannabis market eventually.

Weed Inc.’s CEO stated that the acquisition aimed to provide “double the quality, half the worthwhile creating diversity, and equality in the cannabis sector.”

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