Clinical Trials Conducted on the World’s First Patented Cannabinoid Release Chewing Gum
Medical Marijuana, Inc. (OTC Pink:MJNA) is an agricultural hemp industry innovator that sources, evaluates, invests in and acquires value-adding companies with a focus on industrial hemp. The Company is pleased to announce that one of its investments – AXIM® Biotechnologies, Inc. (OTC:AXIM) – is conducting clinical trials of its patented pharmaceutical chewing gum MedChew™ RX in Europe. The cannabinoid controlled-release chewing gum is the first of its kind and is being developed for patients suffering from pain and/or spasticity associated with multiple sclerosis (MS).
Pain management medications are coming under increased scrutiny, as is evidenced by FDA warnings on the safety of nonsteroidal anti-inflammatory drugs (NSAIDs) from July 2015. The FDA will now require updates to the labels of these medications showing increased risk of heart attack or stroke. Further NSAIDs have a tendency toward injury of the mucosa of the GI tract causing ulceration, bleeding, etc.
“AXIM®‘s MedChew™ RX gum will feature a delivery method that would by-pass the GI issue and carry a high safety of use profile as compared to traditional NSAIDs and opiods or their combinations. Obviously the safety / efficacy issues need to be proven out by clinical trials – nonetheless, I am quite excited to see a new method for delivering effective pain medication,” states MJNA CEO, Stuart Titus, PhD.
Dr. Titus further explains, “It should be well noted that in States where medical marijuana is legal, the incidence of overdose deaths by opioid overdose is 25% lower than in non-medical marijuana states. Presumably because the ability of patients to supplement their pain meds with cannabis / cannabinoids – allows them to take a lower dose of the opioids and still maintain ‘effect’.”
According to American Pharmaceutical Association (APA) spokesperson, Dr. Mary J. West, “The APA is quite impressed with recent reports published by JAMA Internal Medicine, specifically the data showing that in states where it is legal to use medical marijuana to manage chronic pain and other conditions, the annual number of deaths from prescription drug overdose is 25 percent lower than in states where medical marijuana remains illegal.” Dr. West further stated, “We cannot ignore this data.”
Upon approval by the Food and Drug Administration (FDA) and European Medicines Agency (EMA), MedChew™ RX will be formulated with 5 mg of cannabidiol (CBD) and 5 mg of tetrahydrocannabinol (THC) then marketed as a pharmaceutical drug for treatment of pain and spasticity in patients with multiple sclerosis (MS).
AXIM® has found that other cannabinoid delivery methods such as smoking, oral / GI route with reduced uptake have side effects and a reduced efficacy. AXIM® Biotech is developing chewing gum as a new functional method for the uptake of cannabinoids via the oral mucosal membrane as a superior alternative that is safe, effective, discrete and socially accepted.
Dr. Anastassov, MD, DDS, MBA and AXIM® Biotech CEO further states: “An ideal cannabinoid delivery method should allow for predictable and controlled release of the active ingredients, which should bypass the first-pass liver metabolism thus increasing the bioavailability of the cannabinoid and decrease inactive or harmful metabolites. It should not be socially stigmatizing, such as using tablets, capsules, sprays, vapes, etc. It should have a pleasant taste and consistency and lack of undesirable side effects such as uncontrollable psychotropic consequences. It should not induce food cravings and should be economically affordable for both producers and consumers. Chewing gum meets all of these criteria as well as provides multiple additional advantages.”
Lekhram Changoer, MSc, BSc and Chief Technology Officer of AXIM® Biotech states, “AXIM® is pleased to report that the project is on track. After having developed the extracted and purified cannabinoids, the MedChew™ RX drug product is in the process of development whereby different prototypes are developed with a variation of the drug product in different gum layers. This is a very important step in order to create the option to choose for the best drug product after the bioavailability tests in order to assure an effective, sustained release of the drug product in the mucosal membrane area.”
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. To date, AXIM® Biotech’s intellectual property includes many patent applications in various stages with 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 core belief is responsibility for environmental stewardship combined with development of innovative products to address current conditions with no known effective treatment including: Parkinson’s disease, Alzheimer’s disease/dementia, ADHD (attention deficit hyperactivity disorder), PTSD, autism, MS, spasticity, pain, RLS (restless leg syndrome), glaucoma, IBD, IBS and Crohn’s disease.
AXIM® Biotech has been featured by media outlets including: ABC, NBC, CBS, Yahoo News, Telemundo, WGN, Univision, Marijuana Investor News, FOX Business, MainStreet.com, MJ Freeway, Chemical & Engineering News, Dental Tribune, Pharmaceutical Commerce, Dental Products Report and MJI News. For more information, visit AXIM Biotech’s website.
To arrange for media interviews, contact Andrew Hard, Public Relations Spokesperson, at Andrew.Hard@CMWmedia.com or call 858-380-5478.
AXIM® Biotechnologies, Inc. (OTC:AXIM) is an innovative biotechnology Company focusing on research, development and production of pharmaceutical, nutraceutical and cosmetic products where we prioritize the well-being of our customers while embracing a solid fiscal strategy. For more information, visit the Company website at www.AXIMBiotech.com.
About Medical Marijuana Inc.
Our mission is to be the premier cannabis and hemp industry innovators, leveraging our team of professionals to source, evaluate and purchase value-added companies and products, while allowing them to keep their integrity and entrepreneurial spirit. We strive to create awareness within our industry, develop environmentally-friendly, economically sustainable businesses, while increasing shareholder value. For more information, please visit the company’s website at: www.MedicalMarijuanaInc.com
FOOD AND DRUG ADMINISTRATION (FDA) DISCLOSURE
These statements have not been evaluated by the FDA and are not intended to diagnose, treat or cure any disease.
This press release may contain certain forward-looking statements and information, as defined within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and is subject to the Safe Harbor created by those sections. This material contains statements about expected future events and/or financial results that are forward-looking in nature and subject to risks and uncertainties. Such forward-looking statements by definition involve risks, uncertainties and other factors, which may cause the actual results, performance or achievements of Medical Marijuana, Inc. to be materially different from the statements made herein.
Medical Marijuana Inc. and HempMeds do not sell or distribute any products that are in violation of the United States Controlled Substances Act (US.CSA). These companies do grow, sell, and distribute hemp-based products and are involved with the federally legal distribution of medical marijuana-based products within certain international markets. Cannabidiol is a natural constituent of hemp oil.