"That despite the growing acceptance of cannabis at the state level around the country, it really has no bearing on our strategy. The FDA will assess our new drug application (NDA) based only on our scientific data, irrespective of the drug being sourced from natural botanical materials.”
RESTON, Va. (PRWEB) June 11, 2018
MMJ International Holding’s, the premier medical cannabis research company that is advancing the science of medical marijuana through patient clinical research, announced today MMJ’s filing of an Investigational New Drug (IND) application with the FDA to initiate clinical trials assessing the company’s THC/CBD pharmaceutical compounds for treating and/or preventing symptoms associated with multiple sclerosis (MS).
Dr. Bianca Weinstock-Guttman is a Professor of Neurology at the State University of New York at Buffalo who serves as Executive Director of the New York State Multiple Sclerosis Consortium will execute the FDA approved study exploring the potential therapeutic applications of cannabinoids for progressive multiple sclerosis patients. MMJ BioScience’s will be providing new evidence regarding clinical outcomes leading to commercial success in the scientific process of MMJ BioScience’s first pharmaceutical (THC) cannabidiol (CBD) derived medicine.
MMJ’s first clinical trial of cannabis-based medicines involving patients suffering from Multiple Sclerosis and its related forms of severe pain and spasticity will be seeking FDA permission to proceed to undertake a pharmaceutical research study to develop a prescription cannabis-based medicine. MMJ will soon commence their Phase 2 clinical trials with the guidance of their clinical research organization.
Timothy Moynahan Chairman of MMJ stated, ““Our goal is to conduct clinical research and generate safety and efficacy data on our medication to support a comprehensive review by the FDA and approval as a prescription medicine that will deliver consistency and quality for Multiple Sclerosis patients.”
Moynahan further stated "That despite the growing acceptance of cannabis at the state level around the country, it really has no bearing on our strategy. The FDA will assess our new drug application (NDA) based only on our scientific data, irrespective of the drug being sourced from natural botanical materials.”
https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm421168.htm#dietarysuppl