DEA delays production of marijuana drug as potential treatment for MS and Huntington’s disease

By Nina Zdinjak

MMJ International Holdings has partnered with a specialist pharmaceutical solutions company to produce gelatin-encapsulated 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 (HD).

The Providens, Rhode Island-based medical cannabis research company had entered into a supply agreement with MMJ BioPharma Cultivation to supply strain-specific marijuana plants for further processing to potentially gain FDA approval for its drug.

Photo by FilippoBacci/Getty Images

Problems with the DEA

MMJ BioPharma Cultivation applied for DEA bulk manufacturing registration in 2018. The DEA application process has been delayed by years for unknown reasons. The DEA delay has negatively impacted the progress of drug development for patients with MS and HD.

RELATED: Effective Treatment for Multiple Sclerosis with Cannabis Oil and Minimal Side Effects

“As MMJ International Holdings continues its clinical trials, these DEA delays are unprecedented,” said Elio Mariani, PhD, MMJ’s general manager responsible for research and development. “The statutory mandate of the DEA is safety and divergence and facilitating the manufacture of medicines to help patients with chronic diseases.”

Duane Boise, CEO of MMJ International Holdings, commented, “MMJ’s clinical trials will provide patient dosage, safety and efficacy data to the FDA to demonstrate that cannabis can treat essential tremors, a neurological disorder that causes involuntary tremors. We firmly believe that our oral gel-cap drug MMJ, which contains the unique pharmacological properties of the marijuana plant, will be approved by the FDA as a safe and effective drug.”

RELATED: Cannabis for tremors – what is and isn’t working right now

MMJ International Holdings received DEA approval in 2019 to import cannabis-based products from Canada into the United States, a process that required collaboration from multiple government agencies, including the FDA and the US Drug Enforcement Agency (DEA) and Health Canada.

To date, five approved companies are currently listed on the DEA website, but none manufacture a drug like MMJ International Holdings that has been submitted to the FDA to conduct clinical trials.

This article originally appeared on Benzinga and has been republished with permission.