MMJ International Holdings has received DEA approval to ship THC and CBD from Canada. The premier medical cannabis research company will use the cannabis extract derivatives in an oral drug it is developing for the treatment for multiple sclerosis (MS) and Huntington’s disease (HD). A special pharmaceutical solutions company will be supporting MMJ with the FDA and DEA required development API and specialized liquid encapsulation solutions as the company continues to advance to its clinical trials. MMJ International Holdings’ EVP of Research & Development, Elio Mariani, Ph. D, said, “Patients will benefit from cGMP-quality therapies in an accessible and efficient format.” Patients in MMJ’s clinical trials will be administered gelatin capsules containing THC and CBD daily.
The FDA had most recently awarded MMJ International Holdings “Orphan Drug Designation” for its THC and CBD drug formulation which will be used in treatments for Huntington’s Disease. This is a special designation under the Orphan Drug Act (ODA) which provides for granting special status to a drug or biological product to treat a rare disease upon the request of a sponsor. The Orphan Drug Act provides financial incentives to develop drugs for rare diseases that might otherwise not be developed due to the cost of development. Because the rare diseases and conditions affect such a small number of people, a pharmaceutical company that develops an orphan drug may see a relatively small volume of sales, which compared to the cost of drug development, can incur a financial loss.
MMJ is confident that their pharmaceutical products will alleviate patients of 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.” He added, “ We are pleased with the DEA’s cooperation and support to facilitate our company mission to service the unmet needs of patients suffering from these chronic diseases.” The company has several academic institutions preparing to study the effects of cannabis in multiple sclerosis in hopes of providing the necessary data that supports the therapeutic effects of cannabis in treating essential tremors.