ST PETERSBURG, FL / ACCESSWIRE / November 17 , 2019 / MMJ International Holdings, the premier medical cannabis research company, announced that it has signed a manufacturing agreement with a Pharma Solutions Company to manufacture its proprietary THC and CBD gel cap medicine. MMJ International Holdings is developing an oral drug product from natural whole plant extract derivatives from the marijuana plant containing active ingredients from the cannabis plant. MMJ will be utilizing its new product for a FDA approved treatment of multiple sclerosis (MS) and Huntington's disease (HD) for its clinical trials.
"As MMJ International Holdings continues to advance to its clinical trials, a specialty pharmaceutical solutions company will be supporting MMJ with the FDA, DEA required development API and specialized liquid encapsulation solutions," said Elio Mariani, PhD, EVP of research & development.. "Patients will benefit from cGMP-quality therapies in an accessible and efficient format."
Most recently the FDA awarded MMJ International Holdings ″Orphan Drug Designation″ for its THC and CBD proprietary drug formulation which will be used for the treatment of Huntington's Disease. The drugs, MMJ-001 and MMJ-002 are two of MMJ's lead drugs that the company is confident will bring much needed relief to patients suffering from the debilitating effects of Multiple Sclerosis and Huntington's Disease.
"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," said Duane Boise, CEO of MMJ International Holdings. "Patients in the MMJ International holdings clinical trials will receive gelatin capsules containing THC and CBD daily. MMJ International Holdings has several academic institutions preparing to study cannabis in Multiple Sclerosis and Huntington's disease."
MMJ clinical trials will provide the necessary data to prove that cannabis can treat essential tremors, a neurological disorder that causes involuntary shaking. Duane Boise further stated that "Ultimately, there's so much interest in THC and CBD as a treatment modality, so MMJ will be providing the clinical research data necessary to prove patient dosing, safety, and efficacy."
On October 22, 2019 the FDA issued warning letters to several CBD product sellers alleging false, unfounded, unsubstantiated and egregious health claims about their products' ability to limit, treat or cure without sufficient evidence or FDA approval and threatening product seizures, injunctions and sales proceeds reimbursement.
"The FDA is working quickly to further clarify the regulatory approach for products containing cannabis and cannabis-derived compounds like CBD while using all available resources to monitor the marketplace and protect public health by taking action as needed against companies," said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. "We recognize that there is significant public interest in cannabis and cannabis-derived compounds; however, we must work together to fill in the knowledge gaps about the science, safety and quality of many of these products. We are committed to advancing our regulation of these products through an approach that, in line with our mission, prioritizes public health, fosters innovation and promotes consumer confidence."
MMJ International Holdings continues its process of scientific drug development and discovery by FDA protocol development processes, intellectual property portfolio and DEA regulatory manufacturing guidelines.
MMJ International Holdings
SOURCE: MMJ International Holdings