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Pharmaceutical research study aims to develop a prescription cannabis-based medicine

Medical cannabis research company MMJ International Holdings has announced it has filed an application with the Food and Drug Administration (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, Professor of Neurology at the State University of New York and 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 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 diagnosed with MS and its related forms of severe pain and spasticity will be seeking FDA permission to undertake a pharmaceutical research study to develop a prescription cannabis-based medicine. MMJ will soon commence its Phase II clinical trials with the guidance of their clinical research organisation.

Timothy Moynahan Chairman of MMJ said: “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 MS patients.”

Moynahan continued: “That despite the growing acceptance of cannabis at the state level around the country [America], 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.”

Medical cannabis is currently legal in some, but not all states of America. Campaigners continue to fight for its legalisation in the UK.

Source: MS-UK

Date: 11/06/18

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