AXIM Biotech hoping for 2017 release of its pain-relief gum, MedChew Rx, moving into clinical testing
MedChew Rx, by AXIM Biotechnology, Inc., the world’s first patented cannabinoid release chewing gum for pain and spasticity in multiple sclerosis (MS), is moving into clinical testing. If all goes well, the company plans for a global release date of 2017.
Medical cannabis is believed to have considerable promise as a therapy for difficult-to-treat pain associated with disorders like MS and other conditions that cause nerve pain. AXIM Biotech, based in New York and Ridderkerk, the Netherlands, says that if approved as expected by the FDA (U.S. Food and Drug Administration) and the EMA (European Medicines Agency), MedChew Rx — formulated with 5 mg of cannabidiol (CBD) and 5 mg of tetrahydrocannabinol (THC) — will be marketed as a pharmaceutical drug for treating MS.
AXIM and MedChew Rx were profiled in a feature article this week by the Reuters global news agency’s Natalie Grover, documenting AXIM’s early testing of MedChew Rx, being conducted in the Netherlands, and comparing AXIM’s product to U.K.-based GW Pharmaceuticals’ Sativex, which is not as yet approved in the United States, as well as to noncannabis-based Botox, and baclofen, a muscle relaxant.
Among the estimated 400,000 people in the U.S. and 2.5 million worldwide with MS, roughly 80 percent suffer from spasticity, which is frequently treated with baclofen. AXIM anticipates that MedChew Rx could amount to more than $4.8 billion per year in the U.S. market (an estimate it derives from Sativex’s four daily treatments at $8.24 per dose), although Ms. Grover notes that state health systems in some countries, including GW Pharmaceuticals’ home market, do not consider the drug cost-effective enough to justify coverage.
With one of its key corporate objectives being to provide affordable healthcare, AXIM is pitching MedChew Rx as a reasonably priced alternative for several indications, including spasticity and pain in MS. Ms. Grover reported that the company projects being able to price the gum more cheaply than the competition, having secured a significant discount on cannabis through the Dutch government, which has a policy of promoting the drug for medicinal purposes.
In addition to the Netherlands Health Ministry, which is the source of the pharmaceutical-grade cannabis AXIM is using for product development, the company has built a roster of world-class health organizations and science professionals to support its efforts.
The Netherlands-based Bedrocan, which produces full bud, standardized, medicinal cannabis under contract with the the Netherlands’ Ministry of Health, is providing the base materials for AXIM’s clinical trials on MedChew Rx.
Professor John Zajicek, an authority on medical cannabis and its role in the treatment of neurodegenerative diseases, is a member of AXIM Biotech’s advisory board, chair of Clinical Neuroscience at the University of St. Andrews, U.K., and is responsible for conducting AXIM’s clinical trials on spasticity and pain in MS.
The Netherlands-based Syncom BV, which specializes in pharmaceutical chemistry, is responsible for the isolation and purification of the cannabinoid molecules for MedChew Rx.
QPS, a contract research organization specialized in discovery, pre-clinical and clinical drug development, is managing AXIM’s clinical trials. QPS members who are involved in AXIM’s MedChew RX development include Dr. Jan-Bart Hak, division director of Clinical Research at QPS, and Dr. Willem J. (Pim) Meijler, a senior medical advisor for QPS and a pain specialist with years of experience in monitoring cannabis effects in MS patients. The trials will determine the drug’s efficacy and proper dosing.
Dr. Renger Witkamp, a professor of Nutrition and Pharmacology at Wageningen University in the Netherlands and a member of AXIM Biotech’s Advisory Board, is researching new applications for cannabis in diseases related to inflammation, for which AXIM is developing MedChew Rx as treatment.
Through these efforts, AXIM Biotech says it is poised to unveil the world’s next platform for improved and predictable medicine delivery in the convenient medium of chewing gum, and emphasizes that MedChew Rx is expected to have multiple health indication applications outside of pain and spasticity in MS. The company is focused on developing unique proprietary delivery mechanisms for the therapeutic introduction of cannabinoids, and on finding solutions for conditions for which there is currently no effective treatment, including MS, but also pain, spasticity, Alzheimer’s disease/dementia, Parkinson’s disease, PTSD (post-traumatic stress disorder), psychosis, autism, ADHD (attention deficit hyperactivity disorder), glaucoma, RLS (restless leg syndrome), IBD (inflammatory bowel disease), IBS (irritable bowel syndrome), and Crohn’s disease.
“AXIM is very proud and excited to have our efforts open up new drug markets and have the Company’s clinical trials on MedChew Rx documented by a top global news agency such as Reuters,” said Dr. George E. Anastassov, MD, DDS, MBA, chief executive officer of AXIM Biotech, in a release. “The Reuters article correctly documents AXIM’s fast track to a large share of the market and the Company’s place among the very top leaders in the pharmaceutical industry.”
“Although certain similarities in APIs [active pharmaceutical ingredient] with other available or in developmental stage pharmaceuticals exist,” added Dr. Anastassov, “what makes MedChew Rx unique and superior is its precise, controlled release mechanism to the oral mucosal capillary circulation, thus bypassing the first-pass, liver metabolism. Second, it provides neuroprotective and neurostimulatory benefits derived from the act of mastication. These beneficial effects become quite apparent with the recent introduction and FDA approval of QuilliChew ER (methylphenidate HCL in a chewing gum format) for treatment of ADHD by Pfizer.”
Dr. Anastassov also said that, according to Dr. Roxane Weijenberg, the clinical trial coordinator at the Free University of Amsterdam, there is a growing body of evidence suggesting that the act of mastication (chewing) itself has therapeutic effects.
A literature review published in the journal Neuroscience & Biobehavioral Reviews in January 2011, titled “Mastication for the Mind-The Relationship Between Mastication and Cognition in Ageing and Dementia“ and co-authored by Dr. Weijenberg, E.J.A. Scherder, and F. Lobbezoo, investigated the relationship between mastication and cognition, with a special focus on aging and dementia, and possible underlying mechanisms.
The researchers noted that mastication promotes neurogenesis, hypothalamic-hypophiseal-adrenal axis attenuation, cardiovascular stimulation, enriched environment, and promotion of oral health, with positive effects both acute and long-term. Acute mastication effects documented include arousal, cognition, stress reduction, and fresher breath, while 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 points out that traditional cannabinoid delivery methods such as smoking and the oral/gastrointestinal route have side effects and reduced efficacy, maintaining that chewing gum as a method for the uptake of cannabinoids via the oral mucosal membrane is a far superior, safe, and socially accepted delivery method. Professor John Zajicek is cited in an AXIM release observing that, “Chewing gum is a potentially good route as it would avoid respiratory irritations associated with other delivery methods. It will deliver a prolonged dose without peaking too much.”
AXIM Biotech says it “hopes its mint-flavored gum will be on sale in the United States as early as 2017. This will depend on whether the Food and Drug Administration [FDA] grants an accelerated development timeline that would allow it to leapfrog GW [Pharma], which is waiting to discuss with the agency if and how a late-stage study for Sativex will proceed. AXIM thinks its case could be bolstered by research already undertaken by GW, which has established ‘evidence of safety’ for its drugs derived from natural cannabis.”
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