FDA Moves Ahead With MMJ Cannabis Drug Application
MMJ International Holdings Develops Botanical Extract for FDA Clinical Trials in Multiple Sclerosis and Huntington's Disease.
MMJ International Holdings has manufactured a botanical extract in a final dose form gel cap and will investigate its novel cannabis medicine in FDA clinical trials to prove safety and efficacy for treatment in Multiple Sclerosis (MS) and Huntington's disease (HD) patients" stated MMJ President Duane Boise.
MIAMI BEACH, FL / ACCESSWIRE / February 23, 2024 / MMJ International Holdings is one of a very few companies that has followed the federal mandate in its process to win FDA approval for its pharmaceutical cannabis THC, CBD drug. While other companies were trying to circumvent the federal system MMJ's strategy of following the FDA guidances has payed off.
Further supported by the fact that in January, 2023 the FDA denied several petitions that had asked the agency to allow products that contain hemp ingredients to be marketed as dietary supplements, further stating that a clinical trial would be needed to prove safety and efficacy. Federal legalization of marijuana is not imminent and MMJ's strategy of pharmaceutical drug development and clinical trials will show itself as the new cannabis 3.0.
To date, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition. The agency has, however, approved one cannabis-derived synthetic drug product: Epidiolex (cannabidiol), and three other synthetic cannabis-related drug products: Marinol (dronabinol), Syndros (dronabinol), and Cesamet (nabilone). These approved drug products are only available with a prescription from a licensed healthcare provider. Importantly, the FDA has not approved any other cannabis, cannabis-derived, or cannabidiol (CBD) products currently available on the market. MMJ International Holdings is seeking approval as a botanical drug not a synthetic drug.
MMJ International Holdings has provided the FDA enough information to permit an FDA reviewer to reach the following key decisions:
- 1.Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweighs the risks.
- 2.Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain.
- 3.Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity. The documentation MMJ gave the FDA tells the drug's whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the clinical trials (pending), how the drug behaves in the body, and how it is manufactured, processed and packaged.
MMJ recognizes that there is significant public interest in cannabis and cannabis-derived compounds. The MMJ team continues to work diligently with universities and scientist to fill in the knowledge gaps about the science, safety and quality of their products. We are committed to advancing our marijuana cultivation, lab formulations and clinical trials through an approach that is in line with our mission to prioritizes public health, fosters innovation, and promotes consumer confidence.
