The DEA application process is delayed for years for unknown reasons, which negatively impacts the progress of drug development for patients with multiple sclerosis and Huntington’s disease.
PROVIDENCE, RI/ACCESSWIRE/March 13, 2022/ MMJ International Holdings, in conjunction with a specialty pharmaceutical solutions company, manufactures gelatin capsule medications based on compounds found in cannabis. The company will study them in clinical trials as potential treatments for multiple sclerosis (MS) and Huntington’s disease (HD).
MMJ International Holdings had entered into a supply agreement with MMJ BioPharma Cultivation for them to provide strain-specific marijuana plants for further processing to eventually gain FDA approval for its drug.
MMJ BioPharma Cultivation applied for a DEA bulk manufacturing registration in 2018. The DEA application process is delayed for years for unknown reasons. The DEA’s delay has negatively impacted the progress of drug development for MS and HD patients.
“As MMJ International Holdings continues to move toward its clinical trials, these DEA delays are unprecedented,” said Elio Mariani, PhD, MMJ’s executive director responsible for research and development. The DEA’s statutory mandate is safety and divergence and to facilitate the manufacture of pharmaceuticals to help patients with chronic diseases.
The cannabis plant contains many biologically active compounds. The best known are cannabidiol (CBD) and tetrahydrocannabinol (THC), both Schedule 1 substances. “MMJ’s clinical trials will provide the FDA with data on dosing, safety and efficacy in patients to prove that cannabis can treat essential tremor, a neurological disorder that causes involuntary tremors,” said Duane Boise, CEO of MMJ International Holdings. “We strongly believe that our oral capsule drug MMJ, containing the unique pharmacological properties of the marijuana plant, will be approved by the FDA as a safe and effective drug,” Boise said.
In 2019, MMJ International Holdings received clearance from the DEA to import cannabis products into the United States from Canada, a process that required the cooperation of multiple government agencies, including the FDA, Drug Enforcement United States Agency (DEA) and Health Canada.
As of today, five approved entities are currently listed on the DEA website, but none manufactures a pharmaceutical such as MMJ International Holdings with FDA filings to perform clinical trials.
THE SOURCE: MMJ International Holdings
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