AXIM Biotech announced that tests done on its cannabinoid-based chewing gum — MedChew Rx — showed both product stability and effective release of medicinal molecules, with a high percentage of its pharmaceutical ingredients available.
These test results may be of importance, as the company is planning to bring MedChew Rx into clinical trials as a treatment for pain and spasticity in multiple sclerosis (MS) patients.
A press release did not detail these tests, but the company previously reported that it was working with universities in the U.S. and Europe to evaluate its products. In addition to MedChew Rx, its pipeline products include CanChew+, a potential treatment for irritable bowel syndrome.
MedChew Rx is based on the combination of two cannabis components — delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) — both of which are known to degrade over time. For this reason, measures of the gum’s stability, as well as the availability of its active ingredients, were conducted.
The gum was seen to be stable throughout the test, and a dissolution study revealed that more than 90 percent of its active pharmaceutical ingredient was released and available to potentially offer benefit.
“Data from these studies is an essential component in manufacturing as well as regulatory submissions and we are pleased to see such positive results for our MedChew Rx program,” George E. Anastassov, MD, chief executive officer of AXIM Biotech, said in the release.
“While we knew our controlled-release chewing gum delivery system would deliver the molecules with increased bioavailability to the body, we needed to ensure that the molecules would remain stable and available in this format,” Anastassov added. “Not only did we see this, but we measured an industry-leading stability in THC, which is a notoriously unstable molecule.”
Plans for a first clinical trial of MedChew as a potential MS treated of pain and spasticity were approved by Dutch regulators in early 2018. Results from this stability and dissolution study will be valuable for the entire MedChew Rx pharmaceutical development program, testing MedChew to provide symptomatic relief to MS patients.
In addition, “this data will be essential to monitor quality and batch-to-batch consistency of our products after we have received regulatory approval and are selling on the market,” Anastassov said.
The company announced earlier this year that it had patented a new technology to extract high quality, pharmaceutical-grade THC to be used in its formulations.
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