Clinical Trials Study Cannabis Chewing Gum for MS-Associated Pain and Spasticity
AXIM Biotechnologies, Inc. (AXIM)’s clinical trials testing a new pharmaceutical-grade cannabis chewing gum treatment option for Multiple Sclerosis (MS) pain and spasticity are drawing lots of popular and specialty media attention, with reports in Multiple Sclerosis News Today, Marketwatch, Yahoo! Finance, Wall Street Journal, CNN Money, Marijuana Stocks Report, Culture Magazine, and Pharmacy Choice.
A Yahoo! Finance report cited: “A recent North American Research Committee on Multiple Sclerosis (NARCOMS) survey found that the vast majority (95.1 percent) of MS sufferers are in favor of legalized medical marijuana. About 16 percent of the survey respondents reported using marijuana for their MS. More than 80 percent of MS sufferers said they would consider using marijuana if it were legal in their state.”
Medical Marijuana for Pain Relief and Management
AXIM maintains that use of legal medical cannabis can address a variety of therapeutic purposes, with pain relief and pain management typically considered a primary application for medical marijuana recommendation or card holders. Many patients anecdotally report significant improvements in the amount and intensity of pain from ongoing illnesses through use of medical marijuana.
Medical cannabis holds considerable promise as therapy for some specific, difficult-to-treat pain associated with disorders like MS and other conditions that cause nerve pain, according to research findings presented to the California Legislature. The National Institutes of Health MS Website notes that MS patients can experience “burning, tingling, and prickling (commonly called ‘pins and needles’) … sensations that happen in the absence of any stimulation. The medical term for them is dysesthesias. They are often chronic and hard to treat.”
An MSN report cites promising results in a series of trials comparing marijuana cigarettes of varying tetrahydrocannabinol (THC) strengths against traditional painkilling medications in which Igor Grant, M.D., F.R.C.P.(C), executive vice-chairman of the department of psychiatry at the University of California San Diego School of Medicine and director of the Center for Medicinal Cannabis Research at the University of California found that the marijauana pain therapy was comparable and sometimes superior to classic drugs.
A summary by Dr. Grant of research findings on the neuropsychiatirc effects of medical cannabis can be found here in pdf format.
The MSN article also references a review of 13 studies by researchers at the University of California San Francisco who noted that medical marijuana overall may provide relief for chronic neuropathic pain patients that can’t be controlled with other treatments.
However, a major obstacle to widespread general medical deployment of cannabis as a painkiller in the U.S. is the lack of standardized dose delivery, research and development of which has been severely hindered by the fact that while four U.S. states have legalized both medical and recreational marijuana use, and a total of 23 states, the District of Columbia and Guam now allow for comprehensive public medical marijuana and cannabis programs, cannabis remains a Schedule I substance under the Controlled Substances Act, the most tightly restricted category reserved for drugs deemed by the feds to have “no currently accepted medical use.”
In Canada, legal pharmaceutical grade marijuana is available to patients with a doctor’s prescription from federal government licensed suppliers, although marijuana therapy has not been endorsed by the Canadian Medical Association.
Smoking is obviously not a desirable mode of dosing delivery, although vaporization is one workaround that eliminates the issues related to combustion. The MSN article notes that patients in more than two dozen countries have access to Sativex, an oral spray containing several marijuana-derived compounds, including THC and the non-psychoactive cannabioid compound cannabidiol (CBD), and that in one British study of 66 MS patients, 42 percent experienced relief compared to 16 percent in a placebo control group.
AXIM Biotech hopes that its MedChew RX patented cannabinoid release gum will be approved for therapeutic use by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). MedChewRX will be formulated with 5 mg of cannabidiol (CBD) and 5 mg of tetrahydrocannabinol (THC) and marketed as a pharmaceutical drug for multiple sclerosis (MS).
“We have received inquiries from individuals in the U.S. on how to participate in the clinical trials for pain and spasticity with MS,” says George E. Anastassov, MD, DDS, MDA and Chief Executive Officer of AXIM Biotech in a release. “We would like to emphasize that the clinical trials with MedChew RX are taking place in The Netherlands. If any individuals would like to participate in any of AXIM’s future clinical trials, please contact us for details.”
Dr. Anastassov further notes that “AXIM’s clinical trials with pharmaceutical cannabis chewing gum will continue through 2016. The trials are projected to be completed and all data summarized as well as FDA and EMA registration obtained in 2017.”
Dr. Anastassov says the sentiment they’re hearing from MS patients is that current medications are not affordable, especially for individuals whose prescriptions are not covered by insurance, with Forbes reporting one MS drug costing nearly $55,000 per person annually, and Healthline citing MS drugs in the range of $62,000 per year.
By contrast, Dr. Anastassov observes that “The retail prices for MedChew RX will be similar to currently available narcotic analgesics but much less expensive than what is currently on the market. We want to prove our concept in comparison to an existing model for MS.”
“Afterward, AXIM will enter the general pain market,” Dr. Anastassov continues. That market is a major industry with global analgesic sales valued at approximately billion. “AXIM will pursue the pain market as well as others, including neurodegenerative diseases,” he concludes.
AXIM Biotech affirms as core corporate beliefs a responsibility for environmental stewardship combined with development of innovative products to address current conditions with no known effective treatment including: MS, spasticity, pain, Parkinson’s disease, Alzheimer’s disease/dementia, ADHD (attention deficit hyperactivity disorder), PTSD, autism, RLS (restless leg syndrome), glaucoma, IBD, IBS and Crohn’s disease — all of which have been claimed to respond therapeutically to use of medical cannabis.
For the introduction of natural components of the cannabis (hemp) plant known as cannabinoids (e.g. CBD, CBG, THC, etc.), AXIM Biotech is producing a broad scope of proprietary delivery mechanisms, with the company’s intellectual property including many patent applications in various stages and additional inventions to be filed soon including trademark applications; many of them are approved trademarks. All of AXIM’s products are supported by solid intellectual property prior to being produced and distributed worldwide.
As the exclusive license recipient to the world’s first controlled-release chewing gum containing cannabinoids, AXIM Biotechnologies is pursuing two markets: food with CanChew Plus and pharmaceutical with MedChew RX. Award-winning CanChew gum, a food product, is available today; CanChew Plus is planned to be available soon.
AXIM Biotech’s plan utilizes all aspects of the agricultural hemp plant resting in a net negative carbon footprint. AXIM Biotechnologies does not sell or distribute any products that are in violation of the United States Controlled Substances Act (US.CSA). The company does grow, sell, and distribute hemp-based products.
For more information, visit AXIM Biotech’s website at:
AXIM Biotechnologies, Inc.
The National Institutes of Health
Center for Medicinal Cannabis Research at the University of California
AXIM Biotechnologies, Inc.
University of California San Diego School of Medicine