MMJ International Holdings, in collaboration with a a specialty pharmaceutical solutions company, has begun manufacturing gelatin capsule medicines based on compounds found in cannabis, The company will investigate these in clinical trials as potential treatments for multiple sclerosis (MS) and Huntington’s disease.
“As MMJ International Holdings continues to advance to its clinical trials, now a specialty pharmaceutical solutions company will be supporting MMJ,” Elio Mariani, PhD, MMJ’s executive vice president of research and development, said in a press release.
The cannabis plant contains many biologically active compounds. The best-known are cannabidiol (CBD) and tetrahydrocannabinol (THC); the latter is the psychoactive compound primarily responsible for the “high” associated with cannabis consumption.
Among MMJ’s lead therapeutic candidates are MMJ-001 and MMJ-002, both of which are based on a liquid formulation of highly purified CBD and THC, as well as other ingredients, administered in a gel capsule.
MMJ-001 is being developed as a treatment for spasticity (muscle stiffness) in MS. MMJ-002 is an investigational treatment for Huntington’s-associated chorea (a neurological disorder characterized by involuntary jerking movements). MMJ-002 has been designated an orphan drug by the U.S. Food and Drug Administration (FDA).
MMJ is planning to test these investigational therapies in clinical trials.
“MMJ’s clinical trials will provide patient dosing, safety, and efficacy data to the FDA to prove that cannabis can treat essential tremors, a neurological disorder that causes involuntary shaking,” said Duane Boise, CEO of MMJ Biopharma.
“We firmly believe that our MMJ oral gel cap medication, containing the marijuana plant’s unique pharmacological properties, will be FDA-approved as a safe and effective drug,” Mariani said.
MMJ recently was given clearance to bring cannabis-based products into the U.S., a process that required the cooperation of multiple governmental agencies, including the FDA and the U.S. Drug Enforcement Agency (DEA).
The company also reached other milestones recently, including securing agreements with a Native American Indian sovereign nation for DEA-approved growing of cannabis plants and developing an optimized process to extract CBD and THC.
“Our accomplished team has worked within the FDA guidelines to obtain a significant approval from the Center for Drug Evaluation and Research,” said Boise. “MMJ now can proceed to develop our cannabis-derived, whole-plant, natural extracts for our oral gel cap medication’s clinical trials in the United States.”
In related news, the FDA continues to issue warnings to other sellers of CBD products, alleging that the companies have made health-related claims about their products that are false or unsubstantiated.
“The FDA is working quickly to further clarify the regulatory approach for products containing cannabis and cannabis-derived compounds like THC, CBD while using all available resources to monitor the marketplace and protect public health by taking action as needed against companies,” Amy Abernethy, MD, PhD, FDA principal deputy commissioner said in October.
“We recognize that there is 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. We are committed to advancing our regulation of these products through an approach that, in line with our mission, prioritizes public health, fosters innovation and promotes consumer confidence,” Abernethy added.
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