The MMJ trifecta of firms, in partnership with a specialized pharmaceutical soft gelatin production firm, has completed production of its CBD, THC capsule medicine based on compounds in the cannabis plant. The company will conduct clinical trials on its unique pharmaceutical to demonstrate its safety, efficacy, and treatment for individuals with Huntington's disease (HD) and multiple sclerosis (MS).
Once FDA-approved for usage in clinical trials, MMJ will be the only firm offering a CBD and THC pill that will be thoroughly tested in clinical studies. It also implies that this plant-based, non-synthetic, highly purified form of CBD and THC is produced following the FDA's current Good Manufacturing Practices guidelines.
"MMJ International Holdings has pushed carefully for the past five years to formulate the capsule and log in all of the evidence required by the FDA for approval," said Dr. Elio Mariani, MMJ's CEO. The president of MMJ, Duane Boise, also added that among MMJ's lead treatments are MMJ-001 and MMJ-002. Both capsules are based on a colloidal solution of highly purified extracts of THC, CBD, and other compounds from the cannabis plant.
MMJ-001 is being evaluated as a therapy for muscle stiffness (spasticity) in individuals with multiple sclerosis. MMJ-002 is an experimental therapy for Huntington's-related chorea (a neurological disorder with the characteristic symptom of involuntary jerking movements). The US Food and Medication Administration has designated MMJ-002 as an orphan drug (FDA).
"MMJ's clinical trials will provide data to the FDA on patient dose, safety, and efficacy to establish that cannabis can cure critical tremors, a neurological condition that results in involuntary shaking," Duane Boise said. "We are confident that our MMJ oral gel cap medication, which contains the marijuana plant's distinctive pharmacological qualities, will be authorized by the FDA as an effective and safe drug," Tim Moynahan, board chairman, added.
MMJ recently received DEA approval to import cannabis-based goods into the United States, a process that requires the collaboration of various government agencies, including the FDA, Health Canada, and the United States Drug Enforcement Agency (DEA). In addition, the company recently received DEA clearance for a schedule 1 cannabis experimental lab and is seeking final DEA approval for their API Bulk Manufacturing Registration to produce cannabis plants.
"Our competent team was working within the DEA and FDA requirements to acquire all clearances," Boise stated. "MMJ may now move forward with developing our cannabis-derived, natural extracts for our oral gel capsule medications in clinical studies in the United States."
In related news, President Biden signed the Marijuana Research and Expansion Act into law. This will speed up researchers' bids for DEA schedule 1 registration authorization to undertake these trials. After seven hard years of waiting, the MMJ group of firms can finish their mission of performing clinical studies on Huntington's Disease and Multiple Sclerosis. MMJ has received FDA Orphan Designation for its Huntington's disease clinical trials.
The measure explicitly authorizes the Drug Enforcement Administration (DEA) to adopt specific procedures to register;
Practitioners to conduct marijuana research and
Producers supply marijuana for the research.
The measure authorizes MMJ businesses to possess, manufacture, sell, or dispense cannabidiol (CBD) or marijuana (THC) for medical research purposes. The measure also states that the US attorney general will have 2 months to approve or request additional data from the cannabis research applicant. It also makes it easier for MMJ researchers to obtain more significant amounts of cannabis.
The company's CEO, Dr. Elio Mariani, claimed, "In the instance of MMJ, the company is developing a soft gel pill to treat the symptoms of Huntington's Disease and Multiple Sclerosis. Other researchers could potentially use the gel capsule composition in clinical trials ".
The DEA MOA has been issued, and MMJ is on pace to earn a vertically integrated Schedule 1 cannabis production and cultivation license. The firm is also nearing the completion of its state-of-the-art marijuana center of excellence in Rhode Island. The MOA specifies how the firm plans to conduct business with the DEA when a few minor changes are made following the DEA's requirements and the final registration is approved.
"These permits fall under severe DEA monitoring and require stringent regulations of operation, all of which MMJ has met," said Jorge Jimenez, MMJ's head of regulatory compliance. This year, MMJ was granted a schedule 1 analytical lab license. MMJ has teamed with the University of Connecticut since Schedule 1 licenses are generally issued to cultivators linked with an academic institution for research and development.
"MMJ is committed to furthering its research and development through a method that is in accordance with the government's aim to prioritize public health, support innovation, and promote customer trust," commented Duane Boise.
MMJ International Holdings recently secured a DEA license to import its proprietary cannabis extracts into the United States for possible cures for Multiple Sclerosis and Huntington's Disease. After a significant amount of effort, the team has reached vital milestones, which include:
Identified unique cannabis strains for high levels of CBD and THC.
All necessary testing on dried and raw plant "buds" was completed following the FDA Botanical Drug Development Guidance.
Developed a unique extraction method to maximize the levels of both THC and CBD
Analyzed every component present in the extracts for other plant extracts and endocannabinoids.
Chemical and physical stability data for every extract have been established (THC and CBD)
Received DEA approval to import extracts from non-US countries to the US.
Contract with a pharmaceutical business to formulate soft gelatin capsules with a predetermined THC/CBD ratio for phase 2 and 3 clinical trials.
MMJ BioPharma Cultivation has completed arrangements with a sovereign Native American Indian country for a DEA-approved "grow" of the marijuana plant for pharmaceutical, academic, and research companies.
The FDA granted Orphan Drug Approval for their patented soft gelatin dose formulation having a set ratio of THC and CBD for the clinical research of Huntington's Chorea.
MMJ acknowledges the public's interest in cannabis-derived and cannabis substances. The MMJ team is working hard to fill information gaps about their products' chemistry, quality, and safety. "We are committed to developing our cannabis cultivation, lab formulations, and clinical studies in accordance with our purpose of prioritizing public health, fostering innovation, and promoting customer trust," Duane Boise stated.