MMJ International has filed two applications with the U.S. Food and Drug Administration (FDA) requesting permission to begin clinical studies to test its pharmaceutical grade cannabis-based therapies in easing symptoms associated with Huntington’s disease and multiple sclerosis.
MMJ also has requested a meeting with FDA officials to discuss the development process for an investigational new drug (IND). A pre-IND meeting helps create a strategy for the drug development process by reviewing the clinical trial design, sharing ideas, and understanding the specific expectations and requirements for a future IND application. This step, in turn, may shorten the time necessary to bring the product to market.
“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,” said Duane Boise, CEO of MMJ, in a press release.
“The MMJ team expects many advantages by requesting a pre-IND meeting,” Boise added.
If approved, the company will conduct one of the first-ever clinical trials to assess the safety and effectiveness of using a natural botanical cannabis extract as a potential treatment for patients with Huntington’s disease and multiple sclerosis.
The clinical trials should generate new data regarding the benefits of using cannabis-based medicine on clinical outcomes, eventually leading to successful commercial drug development.
Preliminary studies have shown that cannabidiol — the non-psychoactive constituent of cannabis oil — displays neuro-protective qualities. As such, MMJ expects the clinical study will produce positive results and show benefits to treat these patients..
“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 alleviating the suffering of patients,“ Boise said.
MMJ Bioscience, a subsidiary of MMJ International, 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.