New THC-CBD pill for MS and HD could be first to benefit from Biden’s new marijuana research law

The MMJ triangle, in partnership with a specialist pharmaceutical soft gelatin manufacturing company, has completed production of its CBD-THC encapsulated drug based on compounds found in the cannabis plant. The company will conduct clinical trials of its unique drug to demonstrate its safety, efficacy and treatment for people with Huntington’s disease (HD) and multiple sclerosis (MS).

Once the FDA approves it for use in clinical trials, MMJ will be the only company to offer a CBD and THC pill that is thoroughly tested in clinical trials. It also implies that this herbal, non-synthetic, high-purity form of CBD and THC is manufactured according to current FDA Good Manufacturing Practices guidelines.

“MMJ International Holdings has diligently pushed for the past five years to formulate the capsule and provide all the evidence required by the FDA for approval,” said Dr. Elio Mariani, CEO of MMJ. MMJ President Duane Boise added that MMJ-001 and MMJ-002 are among the leading treatments for MMJ. Both capsules are based on a colloidal solution of highly pure extracts of THC, CBD and other compounds from the cannabis plant.

MMJ-001 is being evaluated as a therapy for muscle stiffness (spasticity) in people with multiple sclerosis. MMJ-002 is an investigational therapy for Huntington’s chorea (a neurological disorder characterized by involuntary, jerky movements). The US Food and Medication Administration has designated MMJ-002 as an orphan drug (FDA).

“MMJ’s clinical trials will provide the FDA with patient dose, safety and efficacy data to determine that cannabis can cure critical tremor, a neurological condition that causes involuntary tremors,” said Duane Boise. “We are confident that our oral gel-cap MMJ drug, which contains the distinctive pharmacological properties of the marijuana plant, will be approved by the FDA as an effective and safe drug,” added Tim Moynahan, CEO.

MMJ recently received DEA approval to import cannabis-based goods into the United States, a process that requires the cooperation of various government agencies, including the FDA, Health Canada, and the United States Drug Enforcement Agency (DEA). In addition, the Company recently received DEA approval for a Schedule 1 cannabis testing laboratory and is seeking final DEA approval for its API bulk production registry for the production of cannabis plants.

“Our knowledgeable team worked to obtain all clearances under DEA and FDA requirements,” said Boise. “MMJ can now proceed with the development of our cannabis-derived, natural extracts for our oral gel-cap medications in clinical trials in the United States.”

The Marijuana Research and Expansion Act

In related news, President Biden signed the Marijuana Research and Expansion Act into law. This will expedite investigator applications for DEA Schedule 1 registration approval to conduct these studies. After seven tough years of waiting, the MMJ group of companies can complete its mission of conducting clinical trials in Huntington’s disease and multiple sclerosis. MMJ has received FDA orphan designation for its clinical trials in Huntington’s disease.

The measure expressly authorizes the Drug Enforcement Administration (DEA) to implement specific procedures for registration;

The measure authorizes MMJ companies to own, manufacture, sell or dispense cannabidiol (CBD) or marijuana (THC) for medical research purposes. The measure also states that the US Attorney General has two months to approve or request additional data from the cannabis research applicant. It also makes it easier for MMJ researchers to obtain larger quantities of cannabis.

The company’s CEO, Dr. Elio Mariani, claimed: “In the case 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 track to earn a Schedule 1 vertically integrated cannabis production and cultivation license. The company is also nearing completion of its state-of-the-art marijuana center of excellence in Rhode Island. The MOA sets out how the company plans to conduct business with the DEA if some minor changes are made in accordance with the DEA’s requirements and the final registration is approved.

“These permits fall under strict DEA oversight and require strict operational regulations, all of which MMJ has complied with,” said Jorge Jimenez, MMJ’s head of regulatory compliance. This year MMJ was granted a Schedule 1 Analytic Lab License. MMJ has partnered with the University of Connecticut as Schedule 1 licenses are generally issued to growers affiliated with an academic research and development institution.

“MMJ is committed to advancing its research and development through a methodology consistent with the government’s goal of prioritizing public health, supporting innovation and fostering customer confidence,” commented Duane Boise.

MMJ International Holdings Milestones

MMJ International Holdings recently received a DEA license to import its proprietary cannabis extracts into the United States for potential cures for multiple sclerosis and Huntington’s disease. After significant effort, the team has achieved important milestones, including:

1. Identified unique cannabis strains for high levels of CBD and THC.

2. All required testing on dried and raw plant buds was performed in accordance with the FDA Botanical Drug Development Guidance.

3. Developed a unique extraction method to maximize THC and CBD levels

4. Each component present in the extracts was analyzed for other plant extracts and endocannabinoids.

5. Chemical and physical stability data for each extract has been established (THC and CBD)

6. Received DEA approval to import extracts from non-US countries into the US.

7. Contract with a pharmaceutical company to formulate soft gelatin capsules with a specified THC/CBD ratio for phase 2 and 3 clinical trials.

8. MMJ BioPharma Cultivation has entered into agreements with a sovereign Native American country for DEA-approved “cultivation” of the marijuana plant for pharmaceutical, academic and research companies.

9. The FDA granted Orphan Drug Approval for their patented soft gelatin dosage formulation with a fixed ratio of THC and CBD for Huntington’s disease clinical research.

Conclusion

MMJ recognizes the public’s interest in cannabis-derived and cannabis-derived substances. The MMJ team works hard to fill information gaps about the chemistry, quality and safety of their products. “We are committed to developing our cannabis cultivation, laboratory formulations and clinical studies in alignment with our goal of prioritizing public health, fostering innovation and building consumer confidence,” said Duane Boise.

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