ST. PETERSBURG, FL / ACCESSWIRE / June 15, 2020 / MMJ International Holdings achieving multiple milestones in the development of its marijuana THC (tetrahydrocannabinol), CBD (cannabidiol) pharmaceutical has received approval from The Center for Drug Evaluation and Research (CDER) to proceed with the development of its gel cap formulation.
Most recently MMJ International Holdings had received a DEA permit to import its cannabis proprietary extracts into the United States for use as potential therapies in Huntington's Disease and Multiple Sclerosis.
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 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).
The U.S. Food and Drug Administration (FDA) granted MMJ International Holdings Huntington's orphan drug designation in early 2019, to advance the therapy's development.
Duane Boise, CEO of MMJ commented that "Our experienced team has worked within the federal logistic guidelines to accomplish this significant approval from the Center for Drug Evaluation and Research. 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,"
Dr. Elio Mariana, the companies Executive VP in charge of drug development stated "We firmly believe that our MMJ oral gel cap medication, containing unique marijuana plant pharmacological properties, will be FDA approved as a safe and effective drug,"
Tim Moynahan, MMJ International Holdings Chairman stated "Because cannabis is a federally controlled substance in the U.S., there are numerous legal hurdles that we have cleared in order to proceed with our scheduled clinical trials. Our experienced team has worked within the federal guidelines to accomplish these significant milestones."
Furthermore, these MMJ major accomplishments required the cooperation of many government agencies including the Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), U.S. Customs and Border Protection (CBP), Health Canada and now the Center for Drug Evaluation and Research (CDER) in facilitating our companies mission.
MMJ International Holdings also recently negotiated an agreement with MMJ BioPharma Cultivation, which will be supplying pharmaceutical grade extracts for the companies drug development. MMJ Bio Pharma Cultivation, which has applied for the much coveted DEA federal marijuana growers license and is working with an undisclosed Native American Tribe to grow cannabis plants for this purpose.
SOURCE: MMJ International Holdings