ST. PETERSBURG, FL / ACCESSWIRE / August 25 , 2020 / MMJ International Holdings, the premier medical cannabis research company, announced that it has began manufacturing with an FDA approved Specialty Pharma Solutions Company of its proprietary THC and CBD gel cap medicine. MMJ International Holdings is developing an oral drug product from the marijuana plant extracts. MMJ will be utilizing its new product for a FDA approved treatment of multiple sclerosis (MS) and Huntington's disease (HD) for its clinical trials.
Most recently, MMJ International Holdings received a DEA permit to import its cannabis proprietary extracts into the United States for potential therapies for Huntington's Disease and Multiple Sclerosis. After a considerable amount of work, the team has reach several milestones:
- Identified specific cannabis species for levels of THC and CBD
- Completed all required testing on the raw plant and dried "buds" as mandated by the FDA Botanical Drug Development Guidance
- Developed a specific extraction process to optimize the concentration of both THC or CBD
- Analytically characterized the components in the extracts for other endocannabinoids and plant extracts
- Established physical and chemical stability data for each extract (THC and CBD)
- Received approval from DEA to ship extracts from non U.S. country to to U.S.
- Contracted with a pharmaceutical company to develop soft gelatin capsule formulations to contain a fixed ratio of THC and CBD for phase 2 and 3 clinical studies
- MMJ BioPharma Cultivation successfully completed agreements with a Native American Indian sovereign nation for a DEA approved" grow" of cannabis plants for pharmaceutical, academic and research entities
- Received Orphan Drug Approval from the FDA for the clinical study of Huntington Chorea using our proprietary soft gelatin dosage formulation containing a fixed ratio of THC and CBD
Two of MMJ's lead therapeutic candidates, MMJ-001 and MMJ-002, are liquid formulations containing highly purified THC, CBD, and other active ingredients. MMJ-001 is in development to treat spasticity (abnormal muscle stiffness) in people with multiple sclerosis. MMJ-002 is evolving to treat Huntington' s-associated chorea (involuntary jerking or writhing movements). The FDA granted MMJ-002 orphan drug designation in early 2019, to advance the therapy's development.
"As MMJ International Holdings continues to advance to its clinical trials, now a specialty pharmaceutical solutions company will be supporting MMJ with the FDA, DEA required development API and specialized liquid encapsulation solutions," said Elio Mariani, PhD, EVP of research & development.. "Patients will benefit from cGMP-quality therapies in an accessible and efficient format."
"Our accomplished team has worked within the FDA guidelines to obtain a significant approval from the Center for Drug Evaluation and Research. MMJ now can proceed to develop our cannabis-derived, whole-plant, natural extracts for our oral gel cap medication's clinical trials in the United States," said Duane Boise, CEO of MMJ Biopharma.
Dr. Elio Mariani, the Company's Executive VP in charge of drug development concurs. "We firmly believe 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," he said.
Furthermore, MMJIH has accomplished major goals which required the cooperation of multiple government agencies, including FDA, DEA, U.S. Customs and Border Protection (CBP), Health Canada, and the Center for Drug Evaluation and Research (CDER),
"MMJ's clinical trials will provide patient dosing, safety, and efficacy data to the FDA to prove that cannabis can treat essential tremors, a neurological disorder that causes involuntary shaking", Duane Boise further stated.
The FDA continues to issue warning letters to several CBD product sellers alleging false, unfounded, unsubstantiated and egregious health claims about their products' ability to limit, treat or cure without sufficient evidence or FDA approval and threatening product seizures, injunctions and sales proceeds reimbursement.
"The FDA is working quickly to further clarify the regulatory approach for products containing cannabis and cannabis-derived compounds like THC, CBD while using all available resources to monitor the marketplace and protect public health by taking action as needed against companies," said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. "We recognize that there is significant public interest in cannabis and cannabis-derived compounds; however, we must work together to fill in the knowledge gaps about the science, safety and quality of many of these products. We are committed to advancing our regulation of these products through an approach that, in line with our mission, prioritizes public health, fosters innovation and promotes consumer confidence."
MMJ International Holdings continues its process of scientific drug development and discovery by FDA protocol development processes, intellectual property portfolio and DEA regulatory manufacturing guidelines.
MMJ International Holdings
SOURCE: MMJ International Holdings