Axim Biotechnologies recently announced that its U.K. partner, Quay Pharmaceuticals, has secured licenses from the British Home Office to continue developing and importing its medical cannabinoid product MedChew Rx — a potential treatment for pain and spasticity in people with multiple sclerosis (MS), among other illnesses.
MedChew Rx is a gum containing 5 mg of cannabidiol (CBD) and 5 mg of tetrahydrocannabinol (THC). The gum is intended to offer patients more consistent relief than existing cannabis-derived products that are smoked or eaten.
To develop its CBD-based gums and conduct clinical trials, Axim collaborates with its partners to procure strains of cannabis from the Netherlands, and then extract and purify those strains into pharmaceutical-grade cannabinoids. A Dutch company, Bedrocan, produces these strains at a certified facility under the supervision of the Dutch government’s Office of Medicinal Cannabis.
Axim says several studies are underway at U.S. and European universities to evaluating the effects of its products. Last year, the New York-based company announced plans for a clinical trial assessing MedChew Rx in MS patients at the Free University of Amsterdam, in collaboration with Britain’s University of Plymouth and an unnamed academic center in the United States.
“The development of MedChew RX gum will be carefully formulated to ensure that the drugs are preferentially absorbed orally within a specific window of time to provide the best therapeutic outcome for the patients,” Quay CEO Maireadh Pedersen said in a news release.
Xendo, a consulting firm specializing in the life sciences, pharmaceutical and healthcare industries, is handling regulatory affairs, while QPS, an international clinical research organization, will manage the clinical project and strategies.
“We are excited to move forward the development of MedChew Rx pharmaceutical chewing gum with our world-class research and product development partners,” said Dr. George E. Anastassov, CEO of Axim, noting that the company wants to ensure that its products comply with both U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations.
Anastassov said that “after achieving product stability,” Axim will start efficacy Phase 2A clinical trials at the Free University in Amsterdam, and subsequently move into Phase 3 clinical trials in Vrije Universiteit Amsterdam, for both the U.S. and U.K. markets. Axim expects to finish Phase 3 clinical trials in early 2018.