ST. PETERSBURG, FL / ACCESSWIRE / July 22, 2020 / MMJ International Holdings achieving multiple milestones in the development of its marijuana THC (tetrahydrocannabinol), CBD (cannabidiol) pharmaceutical continues to follow the FDA guidance in the development of its gel cap medicine.
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-002 orphan drug designation in early 2019, to advance the therapy's development.
MMJ International Holdings continues to separate itself from the pack as the Food and Drug Administration (FDA) is publicizing a voluntary recall of dozens of human CBD products after the Florida Department of Health notified a company of lead contamination.
The FDA encouraged consumers to dispose of the products, monitor their health and contact a physician or veterinarian if adverse symptoms are experienced.
"Exposure to lead could present physical signs and symptoms including, pain, paresthesia/muscle weakness, abdominal pain, nausea, vomiting, diarrhea, constipation, poor appetite, weight loss, symptoms associated with encephalitis, metallic taste in the mouth, shock, hemolysis or kidney damage," FDA said in a notice published last week.
Multiple brands of pet hemp oil products recalled for lead contamination. Certain lots of Tasty Drops, Purfurred, Made by Hemp, Herbal Renewals, Barkley Bistro, A Clean Choice, BC Hemp, Boost IV Hydration, Acadia Farms. Stop using these lots immediately.
The FDA currently does not allow for CBD to be marketed as a medicine, food item or dietary supplement without its approval.
On Tuesday, FDA published draft guidance on marijuana and CBD research the recently cleared a White House Office of Management and Budget review which MMJ International Holdings has been following in its development process of it medicine.
In April, the agency sent a warning letter to a CBD company owned by a former NFL player after advertisements it displayed suggested its products could treat and prevent a coronavirus infection.
FDA sent a letter warning to another company about its marketing of injectable CBD products that led to a voluntary recall in May.
The agency also publicized another voluntary recall of another CBD product from a different company, notifying consumers about potentially high levels of lead in a batch of tinctures.
FDA has previously issued warnings to other CBD companies that have made unsubstantiated claims about the therapeutic potential of their products.
Duane Boise, CEO of MMJ commented that "Our experienced team has worked within the FDA guidelines to accomplish a significant approval from the Center for Drug Evaluation and Research. MMJ now can proceed to develop our oral gel cap medication derived from the marijuana whole plant natural extracts for our clinical trials in the United States."
Dr. Elio Mariani, 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 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