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Once approved by the FDA (Food and Drug Administration) and EMA (European Medicines Agency), MedChew RX – formulated Chewing Gum, with 5 mg of cannabidiol (CBD) and 5 mg of tetrahydrocannabinol (THC) – will be marketed as a pharmaceutical drug for multiple sclerosis (MS).
Traditional cannabinoid delivery methods such as smoking, oral / GI route with reduced uptake have side effects and a reduced efficacy. Therefore, AXIM Biotech is targeting chewing gum as a functional method for the uptake of cannabinoids via the oral mucosal membrane as it is a far more superior, safe and socially accepted delivery method.
Dr. Anastassov, MD, DDS, MBA 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.”
AXIM Biotech is obtaining the cannabinoid strains from the Dutch Government’s Bureau of Medicinal Cannabis — delivered by the growing facility Bedrocan BV in The Netherlands. AXIM Biotech has developed with its product development partner, Syncom BV, unique extraction and purification methods for the pharmaceutical-grade cannabinoids and already applied for patents for all of these innovations. The multilayer medical chewing gum with cannabinoids is developed at Fertin Pharma based in Vejle, Denmark. Xendo BV is in charge of the regulatory affairs and QPS BV, a clinical research organization based in The Netherlands, is in charge of managing the entire project including the clinical strategy and trials.
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.”
“The phase 1 PK/PD study activities are planned to start in Q2 of 2016, whereby the release profiles of the different chewing gum products will be compared and a decision will be made on PK/PD analysis. This will determine which of the multilayered gum will be tested on efficacy in Phase 2/3 clinical trials on MS patients,” Dr. Changoer continues. “After completion of the Phase 1 study, Phase 2/3 efficacy patient trials will be started at renowned clinical trial centers in The Netherlands, UK, USA, and others. In The Netherlands the studies are carried out at the VU University in Amsterdam and their respective MS center at the department of Neurology.”
Discussing the further benefits of a chewing-gum delivery mechanism, Dr. Anastassov also explains, “According to Dr. Roxane Weijenberg, PhD, who is the clinical trial coordinator at the Free University of Amsterdam, besides the obvious pharmacological properties of cannabinoids there is a growing body of evidence suggesting that the act of mastication (chewing) itself has therapeutic effects.”
(Weijenberg, R.A., E.J. Chreder, and F. Lobbezoo, Mastication for the Mind-The Relationship Between Mastication and Cognition in Ageing and Dementia. In Neurosci. Biobehav. Rev., 2011.35(3):p. 483-497.)
“This is due to the fact that mastication promotes the following: neurogenesis, hypothalamic-hypophiseal-adrenal axis attenuation, cardiovascular stimulation, enriched environment, and promotion of oral health. The positive effects of mastication are acute and long-term. Acute effects include: arousal, cognition, stress reduction and fresh breath. Long-term effects include: prevention of loss of cognition associated with aging, prevention of dry-mouth due to saliva production stimulation, and improved oral hygiene.”
AXIM Biotech is producing a broad scope of proprietary delivery mechanisms for the introduction of natural components of the cannabis (hemp) plant known as cannabinoids (e.g. CBD, CBG, THC, etc.). AXIM Biotech’s intellectual property, to date, includes many patent applications in various stages of application, with additional inventions to be filed soon, as well as 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 global 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’sdisease/dementia, ADHD (attention deficit hyperactivity disorder), PTSD, autism, MS, spasticity, pain, RLS (restless leg syndrome), glaucoma, IBD, IBS and Crohn’s disease.
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