MMJ Bioscience is in the process of securing orphan drug status from the U.S. Food & Drug Administration for MMJ 001, a CBD derivative, for use as a multiple sclerosis therapy. The company has secured a Health Canada license to produce cannabis for medical purposes to extract active ingredients from cannabis to manufacture gelcaps and has filed an application to begin FDA-approved clinical trials.
“MMJ BioScience also plans to repeat that accomplishment for MMJ-102 for Huntington’s disease. The FDA’s granting of orphan designation for multiple sclerosis is a key step toward that goal. These are debilitating diseases that need new and more innovative treatments, and we look forward to working with the FDA to begin clinical trials to fully explore the potential of cannabis medicines.” – Tim Moynahan, MMJ Bioscience chairman, in a press release
What’s an orphan drug? The FDA grants orphan drug status to drugs and biologics that affected fewer than 200,000 people in the U.S. Orphan drug designation includes benefits such as seven-year marketing exclusivity against competition, federal grants, and tax credits for qualifying clinical trials.
MMJ Bioscience is an affiliate of MMJ International Holdings. The company first filed the new drug application with the FDA in January.