Dutch regulators have signed off on AXIM Biotechnologies’ clinical trial plans for a chewing gum that offers controlled release of cannabinoids to treat multiple sclerosis patients’ pain and spasticity.
The Dutch Medicines Evaluation Board’s sign-off on MedChew Rx means AXIM can start trials.
A leader in cannabinoid research, New York-based AXIM is developing 16 cannabinoid-based pharmaceutical, nutrition and cosmetic products for conditions that include MS, irritable bowel syndrome, and psoriasis.
AXIM officials met with Dutch regulators about the MedChew Rx production process, the way the treatment is delivered, and the information the trials need to generate for the product to be approved.
The regulators agreed that the way AXIM produces the gum’s active ingredients, tetrydrocannabinol (THC) and cannabidiol (CBD), will lead to pure and constant levels of the compounds, the company said. The two molecules are natural ingredients in marijuana.
Approved cannabinoid medicines are based on THC and CBD extracted from marijuana or are made in a lab. Smoking cannabis for medical purposes is however not recommended due to the health risks associated with smoking.
The United States has approved three cannabinoid medicines — Marinol, Syndros and Cesamet. All are synthetic products. None is used for MS.
Europe has approved five cannabinoid-based medicines. One of them, GW Pharmaceuticals’ Sativex, relieves MS spasticity. Sativex contains THC and CBD, the same active ingredients as MedChew Rx, but is administered as a mouth spray.
AXIM developed MedChew Rx chewing gum as an alternative to a spray. The company has reached an agreement with Dutch regulators to compare the performance of MedChew Rx and Sativex in a clinical trial.
The company also plans a Phase 1 trial of MedChew Rx in healthy volunteers to see if it is safe and to obtain information on doses.
“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,” George E. Anastassov, AXIM’s chief executive officer, said in a press release.
“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,” he said.