- MMJ International Holdings is seeking approval from the DEA to import THC and CBD for their clinical trials.
- The FDA has only approved CBD to be used in Epidiolex, an epilepsy medication, so far.
The approval of a cannabis-based epilepsy drug – Epidiolex – made history with the approval from the Food and Drug Administration. Considering the substantial evidence arising over the potential benefits of cannabis, it should come as no surprise that premier medical cannabis research company MMJ International Holdings is seeking to gain approval for another use. According to reports from PR Newswire and Yahoo Finance, MMJ International Holdings is working to ship THC and CBD from Canada in an effort to create an FDA approved treatment for multiple sclerosis and Huntington’s disease (HD).
In order for the clinical trials to commence, MMJ International Holdings is requesting approval from the US Drug Enforcement Agency to allow them to ship the compounds. Elio Mariani, PhD, EVP of research and development, stated,
“As MMJ International Holdings continues to advance to its clinical trials, gel cap manufactures will be supporting MMJ with the FDA, DEA required development API and specialized liquid encapsulation solutions.”
MMJ International Holdings was recently awarded “Orphan Drug Designation” by the FDA, due to the proprietary drug formulation that they developed with THC and CBD to treat Huntington’s disease. The two drugs – MMJ-001 and MMJ-002, are two of the lead drugs that MMJ is confident will bring relief to the patients suffering through Multiple Sclerosis and Huntington’s disease.
Duane Boise, the CEO of MMJ International Holdings, stated that he and his company are confident that their new product will be approved by the FDA “as a safe and effective prescription drug” for MS and HD. Boise 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 chairman, Tim Moynahan, commented that the patients in the clinical trials will be given gelatin capsules, which will be filled with THC and CBD to consume daily. The company already has several academic institutions that will be studying the use of cannabis with the treatment of multiple sclerosis and Huntington’s disease. The trials will allow MMJ to show that cannabis is an effective remedy to handle tremors associated with neurological disorders.
In March, warning letters were issued by the FDA to three CBD product sellers, alleging that they had made false claims about the way that these products can treat consumers without FDA approval or evidence. The FDA added that they would pursue seizure of the products and sales, if the sellers didn’t comply with their requirements.
The warning letters added that CBD:
- Is not presently recognized as safe and effective for the stated purposes of these products.
- Doesn’t have proper “intended use(s) directions” for these products
- Cannot be issued without proper diagnosis or treatment, which cannot presently be done.
Right now, MMJ International Holdings is in the process of development and discovery of these products via the FDA’s protocols in development. The progress will also need to pass the regulatory manufacturing guidelines issued by the DEA.