Early this week, the MMJ International Holdings announced that it has agreed to the production of its proprietary cannabis-based gel capsule. A new product mix of tetrahydrocannabinol (THC) and cannabidiol (CBD) that would comply with the harsh guidelines set by the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA).
The first agreement made with a pharma solutions company hopes to allow MMJ to launch clinical trials of its oral capsule as a new treatment for multiple sclerosis (M.S.) and Huntington’s disease (H.D.).
Both compounds CBD and THC are two of the most abundant cannabinoids found in the plant. CBD is a non-psychoactive compound of marijuana and is said to have neuroprotective properties; still, THC is the primary psychoactive constituent of cannabis.
“We firmly believe that our MMJ natural whole plant-derived molecules with a unique combination of pharmacological properties will be FDA approved as a safe and effective prescription drug that can be of great benefit in treating patients with M.S. and H.D. diseases,” Duane Boise, CEO of MMJ International Holdings, said in a news conference.
The team announced that planned clinical trials are now expected to provide the data needed to show that a marijuana-based product will help patients. Scientists say it will help symptoms like tremors and motor control issues common to several neurological disorders.
In support of this new product, several universities are now developing trials testing the safety and efficacy of daily treatment with MMJ’s gelatin capsules in patients with M.S. and Huntington’s.
“As MMJ International Holdings continues to advance to its clinical trials, a specialty pharmaceutical solutions company will be supporting MMJ with the FDA, DEA,” explained Elio Mariani, Ph.D., executive vice president of research and development.
“Patients will benefit from cGMP [current Good Manufacturing Practice]-quality therapies in an accessible and efficient format.”
The manufacturing company in charge of the new gel cannabis product has not been announced to the public yet.
MMJ-001 and MMJ-002 are climbing the charts in popularity.
MMJ-001 is being made to treat spasticity (muscle stiffness) in M.S., and MMJ-002 to pinpoint and treat Huntington’ s-associated chorea or uncontrolled and involuntary movements.
MMJ-002 was first designed as an orphan drug by the FDA in January as a potential Huntington’s treatment. As the formula for MMJ-001, it is a liquid formulation of highly purified CBD/THC.
Since the legalization of hemp, cannabis programs have been putting CBD in products containing THC-which are not FDA approved. The FDA has sent multiple letters to varies companies warning them to stop all sales and production, alleging they made unsubstantiated claims about the health benefits of their products. Known as benefits to patients “without sufficient evidence or FDA approval.”
Amy Abernethy, MD, PhD, FDA’s principal deputy commissioner, said in one warning, “The agency is working “to clarify further the regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, while using all available resources to monitor the marketplace and protect public health by taking action as needed against companies.”
“We recognize that there is a significant public interest in cannabis and cannabis-derived compounds; however, we must work together to fill in the knowledge gaps about the science, safety, and quality of many of these products,” Abernethy added.
She concluded her warning by, “We are committed to advancing our regulation of these products through an approach that … prioritizes public health, fosters innovation, and promotes consumer confidence.”
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