Axim Biotechnologies Inc (OTCMKTS:AXIM) has announced the successful completion of an exploratory meeting with the Dutch Medicines Evaluation Board on the company’s clinical development program of MedChew Rx®. MedChew Rx® uses cannabinoid molecules in the treatment of patients having pain and spasticity associated with multiple sclerosis (MS).
In the, Axim Biotechnologies and the Dutch authorities had a lengthy discussion on the entire development plan for MedChew Rx in the country as well as across Europe, including its method of delivery, the production process, as well as further studies that may be conducted as to bring the product to market.
The Dutch regulatory agency with the company’s proprietary functional chewing gum delivery method. Additionally, the agency accepted the idea of using this as an alternative method to oral-mucosal spray, which is the current delivery method being used by the only other cannabinoid-based medicine that is being registered in the U.S and in Europe. In addition, the two parties reached an agreement to launch a clinical study to compare the performance of MedChew Rx with other medication options in patients with multiple sclerosis as part of the development plan.
The company also got approval on its proprietary production method that renders a highly purified API product together with steady levels of cannabidiol (CBD) and tetrahydrocannabinol (THC). The approval of this process of production is a clear indication of the company’s capacity to be a global leader not just in research but also in the production of cannabinoid-based pharmaceutical quality products.
While commenting on the new development, AXIM Biotech Chief Executive Officer George E. Anastassov, MD, DDS, MBA said they are very happy with the outcome of the meeting with the Dutch regulators adding that they offered a lot of guidance as well as the necessary approvals to go on with clinical development of the company’s MedChew Rx pharmaceutical product. He added that the meeting is a very important step towards getting a strong strategy for marketing the company’s cannabinoid-based chewing gum in European countries and beyond.
The company, under the guidance of the Dutch Medicines Evaluation Board will launch the MedChew Rx program into a Phase 1 study and will be aimed at confirming the acceptability of the product as well as reducing the variability between the individuals and the number of usage in a day.