Duane Boise stated, "The FDA has made an award for ″Orphan Drug Designation″ for MMJ's THC and CBD proprietary drug formulation which will be used for the treatment of Huntington’s Disease".
ST. PETERSBURG, Fla. (PRWEB) January 07, 2020
MMJ International Holdings, the premier medical cannabis research company, recently announced that the FDA has made an award for ″Orphan Drug Designation″ for its THC and CBD proprietary drug formulation which will be used for the treatment of Huntington’s Disease. The drug, MMJ-002 is one of MMJ’s lead drugs and the company is confident that it will bring much needed relief to patients suffering from the debilitating effects of Huntington’s Disease.
Since 2015, MMJ has been advancing the science of medical marijuana federally legal through development of patient clinical trials and research. This latest award of Orphan Drug Designation is in keeping with MMJ’s mission to do everything possible to improve the lives of patients.
Francis Collins, director of the National Institutes of Health (NIH), recently interviewed on CSPAN, was discussing some of his concerns on marijuana and the lack of research. He mentioned that products must come from a single source and be consistent in clinical trials. Collins stated "When it comes to Cannabis the United States is at an interesting place. In order to use federal funds to research the plant and its compounds, the products must come from a single source: a government-authorized farm at the University of Mississippi that cultivates marijuana.
However, MMJ International Holdings has accomplished a major milestone with the DEA’s recent approval of MMJ International Holdings, THC and CBD international shipment to the United States for Multiple Sclerosis, Huntington's Disease Drug Development. MMJ has established a leading position in the development of plant-derived cannabinoid therapeutics through its proven drug discovery and development processes, intellectual property portfolio and regulatory and manufacturing expertise.
Director Francis Collins also stated, “It’s going to be very hard to interpret data about smoked marijuana when the actual nature of the product is vastly different depending on where you got it with respect to properties like THC and CBD content. We’d really like to have studies where you’re studying those compounds in pure form so you can see what they’re doing,” he said. “But again because of various limitations of Schedule I limits, we are not able to do as much as we would like.”
MMJ International Holdings, having overcome this logistical hurdle, has provided for the production of proprietary cannabis-based gel capsules to help treat those with Huntington’s Disease or Multiple Sclerosis. A new product mix of THC (tetrahydrocannabinol) and CBD (cannabidiol) will comply with the harsh guidelines set by the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA). With MMJ following these guidelines set by the FDA and DEA we can ensure our product is consistent and meets all standards to make it an effective drug for patients who suffer from these debilitating diseases.
MMJ International Holdings already has several academic institutions preparing to study cannabis in Multiple Sclerosis and Huntington's disease. "MMJ clinical trials will provide the necessary data to prove that cannabis can treat essential tremors, a neurological disorder that causes involuntary shaking.” Tim Moynahan the company chairman further stated that, "Ultimately, there's so much interest in THC and CBD as a treatment modality, so MMJ will be providing the clinical research data necessary to prove patient dosing, safety, and efficacy.”
"Approval by DEA and FDA trials is another “big deterrent” to research is the extensive series of hurdles that scientists must overcome to receive approval to study marijuana", Collins said. Researchers must be cleared by the Drug Enforcement Administration (DEA) and also submit an investigational new drug application to the Food and Drug Administration in order to conduct cannabis-involved clinical studies on humans.
"MMJ International Holdings has submitted to the FDA an Investigational New Drug application" stated Duane Boise, CEO. "We are pleased with the FDA 's cooperation and support to facilitate our company mission to service the unmet needs of patients suffering from MS and Huntington's disease.”
"As MMJ International Holdings continues to advance to its clinical trials, 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.”
In conclusion, MMJ International Holdings has established a leading position in the development of plant-derived cannabinoid therapeutics through its proven drug discovery and development processes, intellectual property portfolio and regulatory and manufacturing expertise. MMJ is successfully developing several prescription medications derived from the cannabis plant for the treatment of spasticity and chorea due to multiple sclerosis and Huntington’s disease.
The company has a pipeline of additional clinical stage cannabinoid and other natural botanical product candidates for both orphan and non-orphan indications with a specific focus on neurological conditions.