According to a Phase 1 clinical trial that was recently published in the Journal of Clinical Pharmacology in Drug Development, the oral CBD compound PTL101 is a safe and extremely effective alternative treatment option for patients suffering from spasticity related to multiple sclerosis.
The study is titled “Single-Dose Pharmacokinetics of Oral Cannabidiol Following Administration of PTL101: A New Formulation Based on Gelatin Matrix Pellets Technology.” The trial was conducted by Phytotech Therapeutics.
The study was initially reported in a press release by Harvest One. “CBD is the main non-psychoactive component of the cannabis plant, and it has been associated with neuroprotective, anti-inflammatory, antiseizure, anxiolytic, antidepressant, and antipsychotic effects,” Harvest One stated.
The main objective of this Phase 1 study was to determine how PTL101 is absorbed, distributed, and expelled (for future reference, this is referred to as pharmacokinetics) throughout the body; and whether a 10 or 100 mg dose was more effective. They compared the effects to Sativex, which is a CBD-based oromucosal spray that has been approved for use in hospitals throughout Israel and Europe. The secondary goal was to determine the pharmacokinetics of THC, THC metabolite 11-hydroxy-THC, and CBD after only a single dose.
The trial took place in Israel – as do many of the most prominent cannabis studies - using GelpellR technology, a delivery system that creates small, organic beads of PTL101 beads. This technology was developed by Satipharm, a wholly owned subsidiary of Harvest One based in Switzerland. The study is still in progress and Phase 2 is expected to finish sometime in December.