AXIM Biotechnologies, Inc., a biotechnology company focused on global research, development and production of pharmaceutical, nutraceutical, food and cosmetic products derived from industrial hemp, has announced commencement of clinical development of its leading patented pharmaceutical chewing gum, MedChew RX, for registration as a drug for relieving pain and/or spasticity in patients suffering from with multiple sclerosis (MS).
Once approvals by the FDA (Food and Drug Administration) and its European counterpart EMA (European Medicines Agency) are granted, MedChew RX, which is formulated with 5 mg of the hemp-derived cannabinoids cannabidiol (CBD) and tetrahydrocannabinol (THC) respectively, will be marketed as a pharmaceutical drug for treating multiple sclerosis (MS).
AXIM Biotech notes that traditional cannabinoid delivery methods such as smoking, or the oral/GI route have unwanted side effects and a reduced efficacy. Consequently, the company is targeting chewing gum as a functional vehicle for uptake of cannabinoids via the oral mucosal membrane, observing that gum-chewing is a far superior, safer, and more socially accepted delivery method than for example smoking or vaporizing.
“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 says Dr. George Anastassov, President of AXIM Biotechnologies, Inc. in a release. “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 its supply of 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.
“AXIM is pleased to report that the project is on track,” comments Lekhram Changoer, MSc, BSc and Chief Technology Officer of AXIM Biotech. “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.”
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