George E. Anastassov, MD, CEO of AXIM Biotech, told us the main rationale behind using chewing gum as the delivery system for Cannabidiol (CBD) is that “the oral-pharyngeal mucosa offers extensive territory for rapid and controlled absorption of the API and the avoidance of first pass metabolism.”
“Within 20 minutes, the oral mucosa absorbs 80 to 90 percent of the active ingredient and bypasses the gut and liver metabolism,” added Anastassov. “Chewing gum is also a socially acceptable delivery system of the API compared to smoking and other systems.”Additionally, Anastassov explained mastication is believed to improve cerebral circulation, increase the intestinal motility, enhance memory coordination, and decrease stress.
“The combination of CBD and chewing should have a cumulative effect,” he said.
Ph II clinical trials
The objective of the Phase II A study is to investigate whether the use of a CBD-containing CanChew chewing gum can reduce Irritable Bowel Syndrome (IBS) symptoms and improve the patients perceived wellbeing.
“Functional GI disorders pose an extensive societal and healthcare burden, and negatively affect the quality of life of their sufferers,” said Anastassov.
“Cannabinoids and in particular CBD are well known to positively affect all of the above functions and therefore, are natural choices for the treatment in these cases.”
Forty patients were recruited based on Rome III criteria. The patients range in age from 18 to 65.
AXIM commissioned Professor Renger Whitkamp from the University of Wageningen to conduct the randomized, double-blind, cross-over trial during the eight-week period.
Patients will receive a maximum of six chewing gums per day, either containing 50 mg of cannabidiol per chewing gum or a placebo.
The full study is estimated to complete in June 2017, while final data collection for primary outcome measure is expected in April 2017.
As In-PharmaTechnologist.com previously reported, Axim has partnered with QUAY Pharma, a UK-based contract manufacturer (CMO) for the microencapsulation process and the Delaware-based CRO QPS, which has a unit in Groningen and offers toxicology, DMPK and neruopharmacological services.
AXIM has also acquired land to build its own GMP-compliant manufacturing facility in the Netherlands near Almere, which is under development.