MMJ International has filed two applications with the U.S. Food and Drug Administration (FDA) requesting permission to begin clinical studies testing its pharmaceutical grade cannabis-based therapies in easing symptoms associated with multiple sclerosis and Huntington’s disease.
“The filing of these applications with the FDA brings us one step closer to helping persons suffering from these debilitating diseases. As a company, we are committed to researching and developing cannabis based medicines which will improve the lives of people around the world,” Duane Boise, CEO at MMJ International, said in a press release.
The company also has requested a meeting with FDA officials to discuss the development process for an investigational new drug (IND). A pre-IND meeting with the FDA can help in creating a strategy for the drug development process by reviewing the clinical trial design, sharing ideas, and understanding the specific expectations and requirements for an IND application in the future.
“The MMJ team expects many advantages by requesting a pre-IND meeting,” Boise said.
If approved, the company will be conducting its first-ever clinical trial, testing the effectiveness of natural botanical cannabis extracts as a treatment option for MS and Huntington’s disease, both neurodegenerative disorders.
Previous studies have shown that cannabidiol (CBD), the non-psychoactive component of marijuana, can alleviate spasticity in MS patients. Based on such findings, MMJ anticipates positive outcomes from its trial and is hopeful it will provide new evidence to support the drug development process.
“Our unique scientific approach sets us apart from others in the industry, and we are working hard to create new and innovative pathways geared towards helping doctors treat and [alleviate] the suffering of patients,“ Boise said, acknowledging his team of scientists and industry experts worldwide who have helped develop the company’s portfolio in plant-derived cannabinoid formulations.
In June 2018, MMJ Bioscience, a subsidiary of MMJ International, also applied for a Phase 2 study to evaluate tetrahydrocannabinol (THC)/CBD compounds to ease symptoms in MS patients. MMJ Bioscience is the first company to obtain a license from Health Canada to grow medical marijuana in Canada, and extract cannabinoids from the plant to use in FDA-approved clinical trials.