Multiple government agencies have cooperated to allow MMJ International Holdings to import cannabis extracts to the United States, for use in potential therapies the company is developing for clinical trials in Huntington’s disease and multiple sclerosis.
The cannabis plant makes numerous compounds called cannabinoids, two of the most abundant of which are tetrahydrocannabinol (THC) and cannabidiol (CBD). THC is psychoactive (it causes the “high” associated with marijuana use). CBD is not psychoactive, but has numerous other effects in the body. Preliminary data have suggested that cannabinoids could ease symptoms in numerous neurological conditions, including Huntington’s.
Two of MMJ’s lead therapeutic candidates, MMJ-001 and MMJ-002, are liquid formulations containing highly purified THC and CBD. MMJ-001 is being developed to treat spasticity (abnormal muscle stiffness) in people with multiple sclerosis. MMJ-002 is being developed to treat Huntington’s-associated chorea (involuntary jerking or writhing movements).
“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 in a press release.
Because cannabis is a federally controlled substance in the U.S., there are numerous legal hurdles that have to be cleared in order to study it.
MMJ submitted a request to import CBD and THC from Canada in mid-2019. That request was later approved by the U.S. Drug Enforcement Administration (DEA). The import also required the cooperation of other government agencies, including the FDA, the U.S. Customs and Border Protection (CBP), and Health Canada.
“We are pleased with he FDA, DEA, CBP, and Health Canada’s 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,” said Timothy Moynahan, MMJ’s chairman.
“Our experienced team has worked within the federal logistic guidelines to accomplish this significant milestone. We now can develop our oral gel cap medication, derived from the marijuana whole plant natural extracts for our clinical trials in the United States,” added Duane Boise, CEO of MMJ.
MMJ International Holdings also recently negotiated an agreement with MMJ BioPharma Cultivation, which will be supplying pharmaceutical grade extracts for drug development. MMJ Bio Pharma Cultivation, which has applied for a DEA federal marijuana growers license, is working with an undisclosed Native American tribe to grow cannabis plants for this purpose.