MMJ International Holdings Receives Health Canada- DEA Approval To Ship THC For Drug Development
ST. PETERSBURG, FL / ACCESSWIRE / February 19, 2020 / MMJ International Holdings, the premier medical cannabis research company, announced that it has received approval from Health Canada to ship THC and CBD from Canada.
MMJ International Holdings is developing an oral drug product from natural whole plant extract derivatives from the marijuana plant containing THC and CBD. MMJ will be utilizing its new product for a FDA approved treatment for multiple sclerosis (MS) and Huntington's disease (HD). It also received the US Drug Enforcement Agency's approval to ship the compounds 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. "We are pleased with Health Canada's approval, and the DEA 's cooperation to facilitate our company mission to service the unmet needs of patients suffering from these chronic diseases."
Tim Moynahan the company chairman stated that "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. Tim Moynahan 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."
EFFICACY THROUGH CLINICAL TRIALS
With the MMJ's proper formulation of THC and cannabinoids Health Canada and the DEA has afforded MMJ the opportunity to supply its FDA approved clinical trials. MMJ International Holdings FDA studies will begin shortly in Multiple Sclerosis and Huntington's disease. MMJ's is in collaboration with a major US Pharma Solutions Company that develops and produces drug delivery systems. The Pharma Solutions Company offers manufacturing, packaging, storage, and inventory management services for FDA approved drugs, biologics, and consumer health products.
STATE TO STATE MARIJUANA BUSINESSES AT RISK
Recently, President Tump's budget proposal would remove protections for medical marijuana states and block Washington, D.C. from legalizing sales.The reason why the federal Government is opposed to the state to state federally illegal marijuana products is because "There is a significant gap in our understanding of their impact on health," Nora Volkow, Director of NIDA said.
Furthermore, "The recent outbreaks of e-cigarette or vaping product use associated lung injury (EVALI), which has been linked to informally-sourced THC-containing vape products, underscores the critical importance of facilitating researcher access to different product sources."
The budget proposal will allocate about $4 million to an initiative designed to "better regulate THC and cannabis-derived substances in FDA-regulated products. It will also "support regulatory activities, including developing policies and continue to perform its existing regulatory responsibilities including review of drug product applications, inspections, enforcement, and targeted research." Th FDA is committed to protecting the public health and improving regulatory pathways for the lawful marketing of THC and cannabis-derived products within the agency's jurisdiction.
In many cases, product developers make unproven claims to treat serious or life-threatening diseases, and patients may be misled to forgo otherwise effective, available therapy and opt instead for a product that has no proven value or may cause them serious harm."
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 to protect the public health interest.
SOURCE: MMJ International Holdings