DEA application process is being delayed for years for reasons unknown thus negatively impacting the progression of the drug development for patients suffering from Multiple Sclerosis and Huntington’s disease.
PROVIDENCE, RI / ACCESSWIRE / March 13, 2022 / MMJ International Holdings, in collaboration with a specialty pharmaceutical solutions company, has been 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 (HD).
MMJ International Holdings had entered into a supply agreement with MMJ BioPharma Cultivation for them to supply strain specific marijuana plants for further processing to potentially obtain FDA approval for its drug.
MMJ BioPharma Cultivation has applied for a DEA bulk manufacturing registration in 2018. The DEA application process is being delayed for years for reasons unknown. The DEA delay has negatively impacted the progression of the drug development for patients suffering from MS and HD.
“As MMJ International Holdings continues to advance to its clinical trials, these DEA delays are unprecedented,” stated Elio Mariani, PhD, MMJ’s executive responsible for research and development. The statutory mandate of the DEA is security and divergence and to facilitate the manufacturing of pharmaceuticals to help patients suffering from chronic disease.
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 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 International Holdings. “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,” Boise said.
MMJ International Holdings in 2019 was given DEA clearance to import cannabis-based products into the U.S. from Canada, a process that required the cooperation of multiple governmental agencies, including the FDA and the U.S. Drug Enforcement Agency (DEA) and Health Canada.
To date five approved entities are currently listed on the DEA website but none are manufacturing a pharmaceutical such as MMJ International Holdings with filings with the FDA to perform clinical trials.
SOURCE: MMJ International Holdings
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