MMJ International Holdings announced that it has been given clearance to ship its cannabis-based products to the U.S. for use in future clinical trials of potential cannabis-based treatment for multiple sclerosis (MS) and Huntington’s disease.
The process was facilitated by the U.S. Drug Enforcement Agency (DEA), which worked alongside the U.S. Food and Drug Administration (FDA), the U.S. Custom Border Protection, and Health Canada, as cannabis is a federally controlled product in the U.S.
“We are pleased with the … joint cooperation in facilitating our companies mission to study the positive effects that this medication will have on our multiple sclerosis and Huntington’s disease patients during our clinical trials” in the U.S., Timothy Moynahan, chairman and attorney of MMJ, said in a press release.
These authorizations, requested in 2019, allow the shipment of cannabidiol (CBD) and tetrahydrocannabinol (THC), two of the most abundant cannabinoids found in the cannabis plant, needed for MMJ to develop the gelatin capsules that will be given to patients during clinical trials.
MMJ-001 and MMJ-002 are among the company’s lead therapeutic candidates. MMJ-001 is being developed to treat spasticity (muscle stiffness) in MS, and MMJ-002 to treat Huntington’s-associated chorea — a neurological disorder characterized by involuntary jerky movements.
Both MMJ-001 and MMJ-002 are based on a liquid formulation of highly purified CBD/THC, and will be given to patients in these trials as liquid-filled gel capsules.
“We firmly believe that our MMJ oral gel cap medication, containing unique pharmacological properties, will be FDA approved as a safe and effective drug,” Elio Mariani, PhD, executive vice president of MMJ, said.
The company recently entered into an agreement with MMJ BioPharma Cultivation, which has applied for a DEA-approved license to cultivate marijuana.
MMJ Bio Pharma Cultivation is working with an undisclosed Native American Indian tribe to grow the marijuana that will be used as a source for the CBD/THC extracts MMJ needs to develop its medicinal cannabis-based products.
In addition to MS and Huntington’s, MMJ is looking to develop its products to treat chronic conditions that include cancer, epilepsy, sleep disorders, addiction, depression, and fatigue.
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