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Clinical Trial in IBS Begins for Cannabis-based Chewing Gum
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Axim Biotechnologies has initiated a clinical trial of its non-prescription hemp-derived cannabinoid functional chewing gum for the treatment of patients with irritable bowel syndrome.
Cannabidiol (CBD) has been “shown to have promising effects, but there has been a clear need for practical and effective formulations,” Renger Witkamp, PhD, professor and chair of nutrition and pharmacology at Wageningen University, said in a press release. “Providing it via a chewing gum results in sustained release of the compound and better bio-availability.”
Following recently announced positive results from a pharmacokinetic study, researchers from Wageningen University in the Netherlands and Axim Biotech will randomly assign 40 adults with IBS to receive up to six pieces of controlled-release CanChew Plus CBD gum per day (50 mg CBD per serving) or placebo to determine its efficacy for alleviating stomach cramps, bloating, pain and other symptoms. Perceived pain reduction will serve as the primary endpoint, and general relief and change in stool frequency will also be evaluated, according to the press release.
If outcomes are positive, the company will “proceed immediately with further trials on our pharmaceutical grade CanChew Rx products to treat inflammatory bowel disease (IBD), ulcerative colitis and Crohn’s disease,” George E. Anastassov, MD, DDS, MBA, CEO of Axim Biotech, said in the press release. “We are committed to finding research based cannabinoid solutions to help people suffering from gastrointestinal disorders and other health conditions with no effective remedies.”
This news follows a recent report released just last week by the National Academies of Sciences, Engineering, and Medicine in the U.S., which identified the lack of evidence on the effectiveness of cannabis and cannabinoids for the treatment of IBS as a significant research gap that should be investigated by diverse stakeholders.
Disclosures: Anastassov is employed by Axim Biotech. Witkamp reports he is an advisor for Axim Biotech.