US Agency Asked to OK Cannabinoid Shipments from Canada to Support Studies in MS, MMJ Announces
MMJ International Holdings, a pharmaceutical company whose focus is plant-derived cannabis products for therapeutic purposes, has requested permission to ship tetrahydrocannabinol (THC) and cannabidiol (CBD) from Canada to the U.S. to be used in upcoming clinical trials for people with multiple sclerosis (MS) and Huntington’s disease.
MMJ-001 and MMJ-002 are among the company’s lead therapeutic candidates. MMJ-001 is being developed to treat spasticity (muscle tightness) in MS, and MMJ-002 to treat Huntington’s-associated chorea — a neurological disorder marked by involuntary jerky movements, especially in the shoulders, hips, and face.
Both medications contain THC and CBD, two of the most abundant cannabinoids found in the cannabis plant. CBD is a non-psychoactive component of cannabis and believed to have neuro-protective properties, while THC is the main psychoactive constituent of cannabis.
MMJ-002 was designated an orphan drug by the the U.S. Food and Drug Administration (FDA) in January as a potential Huntington’s treatment. Like MMJ-001, it is a liquid formulation of highly purified CBD/THC.
The request to ship cannabinoid compounds from Canada was filed with the U.S. Drug Enforcement Agency (DEA), the company said in a press release. The DEA, in turn, is asking MMJ to provide the active pharmaceutical ingredients (APIs) of its proprietary THC and CBD formulations to be used in the trials, which were not detailed in the release.
“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 [Huntington’s] diseases,” said Duane Boise, chief executive officer of MMJ.
“We are pleased with the DEA ’s cooperation and support to facilitate our company mission to service the unmet needs of patients suffering from these chronic diseases,” Boise added.
The two therapeutic agents will be made available as liquid-filled gelatin capsules.
“Patients in the MMJ International holdings clinical trials will receive gelatin capsules containing THC and CBD daily. MMJ International Holdings has several academic institutions preparing to study cannabis in Multiple Sclerosis and Huntington’s disease,” Tim Moynahan, chairman of MMJ, said.
The company entered into a partnership with Thermo Fisher Scientific to manufacture its products for the MS and Huntington’s studies. Under the terms of the May agreement, MMJ will will develop the active pharmaceutical ingredient for the capsules.
“As MMJ International Holdings continues to advance to its clinical trials, ThermoFisher Scientific will be supporting MMJ with the FDA, DEA required development API for MMJ’s specialised liquid encapsulation solutions,” said Elio Mariani, the company’s executive vice president of research & development, said in a release at that time.
“Patients will be expected to benefit from cGMP-quality [current Good Manufacturing Practice] therapies in an accessible and efficient format,” Mariani added.