The Dutch Medicines Evaluation Board has signed off AXIM Biotechnologies’ MedChew Rx clinical development programme, which will see them develop and trial a cannabis based chewing gum.
The MedChew RX clinical trial program utilises cannabinoid molecules for the treatment of patients experiencing pain and spasticity associated with multiple sclerosis (MS).
The Dutch regulatory agency expressed enthusiasm about AXIM’s proprietary functional chewing gum delivery method and accepted the concept of using this as an alternative option to oral-mucosal spray. This is currently the delivery method being used by Sativex the only other cannabinoid-based medicine currently registered in the country and in Europe.
In addition, an agreement was reached by the two parties to perform a clinical study to compare the performance of MedChew Rx with the other approved medication in patients with MS as part of the development plan.
AXIM also received approval on its proprietary method of production that renders a highly purified API product with steady levels of tetrahydrocannabinol (THC) and cannabidiol (CBD). These are the same natural active ingredients extracted from marijuana that are also used to make Sativex.
'We are extremely pleased with the outcome of our meeting with the Dutch regulators who provided us with guidance and the approvals necessary to move forward with clinical development of our MedChew Rx pharmaceutical product,' said George E. Anastassov, Chief Executive Officer of AXIM Biotech. 'This meeting marks an important step toward securing a solid strategy for marketing Axim’s cannabinoid-based chewing gum in all countries throughout Europe and beyond.'
Under the guidance of the Dutch Medicines Evaluation Board, AXIM will move its MedChew Rx program forward into a Phase I study on healthy volunteers, aiming to confirm the acceptability of its product and reducing the variability between individuals and the number of administrations over the day.