MMJ International Holdings announced that it has entered into an agreement for the production of its proprietary cannabis-based gel capsule — a product mix of tetrahydrocannabinol (THC) and cannabidiol (CBD) — in compliance with guidelines set by the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA).
THC and CBD are two of the most abundant cannabinoids found in the cannabis plant. CBD is a non-psychoactive component of cannabis and believed to have neuroprotective properties, while THC is the main 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 MS and HD diseases,” Duane Boise, CEO of MMJ International Holdings, said in a press release.
Planned clinical trials are expected to provide the data necessary to demonstrate that cannabis-based products help patients to manage the tremors and motor control issues common to several neurological disorders.
Several academic institutions are now preparing trials testing the safety and efficacy of daily treatment with MMJ’s gelatin capsules in people with MS and Huntington’s, Boise said.
“As MMJ International Holdings continues to advance to its clinical trials, a specialty pharmaceutical solutions company will be supporting MMJ with the FDA, DEA,” said Elio Mariani, PhD, executive vice president of research and development. “Patients will benefit from cGMP [current Good Manufacturing Practice]-quality therapies in an accessible and efficient format.”
Its release did not identify the pharma solutions company that will handle manufacturing of the gel capsules.
MMJ-001 and MMJ-002 are among the company’s lead therapeutic candidates. MMJ-001 is being developed to treat spasticity (muscle stiffness) in MS, and MMJ-002 to treat Huntington’s-associated chorea, or uncontrolled and involuntary movement.
MMJ-002 was designated an orphan drug by the FDA in January as a potential Huntington’s treatment. Like MMJ-001, it is a liquid formulation of highly purified CBD/THC.
The FDA sent warning letters to several companies selling cannabis-based products containing CBD in October, MMJ notes in its release, alleging they made unsubstantiated claims about the health benefits of their products’ benefits to patients “without sufficient evidence or FDA approval.”
The agency is working “to further clarify 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,” Amy Abernethy, MD, PhD, FDA’s principal deputy commissioner, said in one warning noted by MMJ.
“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,” Abernethy aded. “We are committed to advancing our regulation of these products through an approach that … prioritizes public health, fosters innovation and promotes consumer confidence.”