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Oral Cannaidiol Meets Goals of Phase 1 Study as Possible Spasticity Treatment

December 18, 2017

Oral cannabidiol, PTL101, has been discovered as a safe and effective potential treatment of spasticity in multiple sclerosis and conditions such as epilepsy. Results of a Phase 1 clinical trial in healthy volunteers have been announced by Harvest One Cannabis in the study, “Single Dose Pharmacokinetics of Oral Cannabidiol Following Administration of PTL101: A New Formulation Based on Gelatin Matrix Pellets Technology.”

Evaluating the safety, pharmacokinetic (the way a drug is absorbed, distributed and expelled) and tolerability of PTL101 capsules were the objectives of this Phase 1 study. The capsules were administered with either 10 or 100mg of cannabidiol (CBD). Sativex, a therapy approved across Europe to treat spasticity in MS patients which is also based on CBD compounds, was used as a comparison.

Another goal of the study was to compare the pharmacokinetic profile of THC (THC metabolite 11-hydroxy-THC and/or CBD) following a single administration.

The main non-psychoactive component of the cannabis plant is CBD, which is associated with neuroprotective, anti-inflammatory, antiseizure, anxiolytic, antidepressant and antipsychotic effects.

The trial was conducted using a delivery system that was used to create PTL101 beads that contained the CBD. The results showed the safety and high performance of the CBD delivery and that PTL101 capsules had a promising bioavailability when it was compared to Sativex.

There is a Phase 2 clinical trial that is evaluating the effectiveness of PTL101 capsules for treating pediatric refractory epilepsy which is taking place in Israel. Many studies have stated that cannabis-derived products can benefit those with MS as well as other conditions with spasticity symptoms. A possible Phase 2 clinical trial for PTL101 is also in the process of being planned.

Via MS News Today