"We are committed to advancing our marijuana cultivation, lab formulations and clinical trials through an approach that is in line with our mission to prioritizes public health, fosters innovation, and promotes consumer confidence," Duane Boise added.

PROVIDENCE, RI / ACCESSWIRE / December 16, 2022 / MMJ BioPharma Labs, MMJ BioPharma Cultivation, and MMJ International Holdings, takes the lead in he field of federal legal cannabis research, pharmaceutical drug development, and cultivation of high quality marijuana for the development and commercialization of its proprietary cannabinoid-derived medicine.

The MMJ triad of companies in collaboration with a specialty pharmaceutical soft gelatin manufacturing company, has completed manufacturing of its THC, CBD capsule medicine formulated on compounds found in the cannabis plant. The company will investigate its novel pharmaceutical in clinical trials to prove safety, efficacy and treatment for multiple sclerosis (MS) and Huntington's disease (HD) patients.

Once FDA approved for use in clinical trials MMJ will be the only company with a THC and CBD pill that will be thoroughly evaluated in clinical trials. It also means that this plant-based, never synthetic, highly purified form of THC and CBD is manufactured to meet the high standards of the FDA's current Good Manufacturing Practices guidelines.

"MMJ International Holdings has worked diligently for the past five years to develop the pill and all the data the FDA has mandated for approval " Dr. Elio Mariani, MMJ's CEO stated.

Duane Boise, President of MMJ stated "Among MMJ's lead therapeutics are MMJ-001 and MMJ-002, both of which are based on a liquid formulation of highly purified natural plant extracts of CBD and THC, as well as other ingredients".

MMJ-001 is being developed as a treatment for spasticity (muscle stiffness) in MS. MMJ-002 is an investigational treatment for Huntington's-associated chorea (a neurological disorder characterized by involuntary jerking movements). MMJ-002 has been awarded a FDA orphan drug designation by the U.S. Food and Drug Administration (FDA).

"MMJ's clinical trials will prove patient dosing, safety, and efficacy data to the FDA to demonstrate that cannabis can treat essential tremors, a neurological disorder that causes involuntary shaking," said Duane Boise.

"We firmly believes that our MMJ oral gel cap medication, containing the marijuana plant's unique pharmacological properties, will be FDA-approved as a safe and effective drug," Tim Moynahan board chairman further stated.

MMJ recently was given DEA clearance to bring cannabis-based products into the U.S., a process that required the cooperation of multiple governmental agencies, including Health Canada, the FDA and the U.S. Drug Enforcement Agency (DEA).

The company has also reached other milestones recently, including the DEA-approval for a schedule 1 cannabis analytical lab and is awaiting final DEA approval for its API Bulk Manufacturing Registration to grow cannabis plants.

"Our accomplished team has worked within the DEA, FDA guidelines to obtain all approvals"said Boise. "MMJ now can proceed to develop our cannabis-derived, whole-plant, natural extracts for our oral gel cap medication's in clinical trials in the United States."

In related news, President Biden recently signed into law the Marijuana Research and Expansion Act that will expedite researchers applications for DEA schedule 1 registration approvals to preform these trials.

MMJ recognizes that there is significant public interest in cannabis and cannabis-derived compounds. The MMJ team continues to work diligently to fill in the knowledge gaps about the science, safety and quality of their products. We are committed to advancing our marijuana cultivation, lab formulations and clinical trials through an approach that is in line with our mission to prioritizes public health, fosters innovation, and promotes consumer confidence," Duane Boise added.

CONTACT:
Sara Parker
media@mmjih.com
203-231-8583

SOURCE: MMJ International Holdings

View source version on accesswire.com:
https://www.accesswire.com/732150/MMJ-Completes-THC-CBD-Drug-Manufacturing-Awaiting-DEA-and-FDA-Final-approvals-for-MS-and-HD-clinical-trials