Recently, the premier medical cannabis research company MMJ International Holdings signed a manufacturing agreement with a Pharma Solutions Company to produce its cannabis-derived medicine. The oral drug contains whole plant extract derivatives and active ingredients from the cannabis plant. MMJ intends to use the new product for FDA-approved treatment of multiple sclerosis and Huntington’s disease for its clinical trials. MMJ’s medicine takes the form of a gel capsule featuring the cannabinoids THC and CBD.
EVP of research and development at MMJIH Dr. Elio Mariani, Ph.D., mentioned that a specialty pharmaceutical solutions company will be supporting MMJ throughout the process of its clinical trials, assisting with the FDA and DEA required development API and specialized encapsulation solutions. The FDA had awarded MMJ International Holdings “Orphan Drug Designation” for its proprietary drug formulation which will be used for the treatment of Huntington’s disease.
The company is confident that the drugs will bring relief to patients suffering from the effects of multiple sclerosis and Huntington’s disease. Duane Boise, CEO of MMJ International Holdings said, “We firmly believe that our MMJ natural whole plant-derived molecules with a unique combination of pharmacological properties will be FDA approved as a safe and effective prescription drug that can be of great benefit in treating patients with MS and HD diseases.” Boise mentioned that his company has several academic institutions preparing to study cannabis in multiple sclerosis and Huntington’s disease.
The clinical trials will provide the necessary data that cannabis can treat essential tremors, a neurological disorder that causes involuntary shaking. With so much interest in THC and CBD as a treatment modality, MMJ will be providing valuable data and insights regarding patient dosing, safety, and efficacy.
In late October, the FDA issued warning letters to several CBD product sellers on the grounds of false and unsubstantiated health claims about their products’ ability to treat or cure without sufficient data or FDA approval. The FDA is taking steps to protect public health by monitoring the marketplace and clarify the regulatory approach to products containing cannabis and its derived compounds.
In continuing with its process of scientific drug development and discovery, MMJ International Holdings adheres to FDA protocol development processes, intellectual property portfolio, and DEA regulatory manufacturing guidelines.