MGC Pharma has stated that its epilepsy treatment – CannEpil – was found to be safe for post-driving activities.
The clinical study was designed to assess the impact of a 1mL CannEpil dose of 20:1 CBD to delta THC on driving performance, sedation and mood.
CannEpil’s formulation is designed to treat drug resistant epilepsy with this high CBD, low THC formulation, which incorporates Graft Polymer’s GraftBio self-nanoemulsifying drug delivery system.
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The study, carried out by the Swinburne University of Technology under the auspices of the Medical Cannabis Research Collaboration and sponsored by Cannvalate Australia, included the use of a driving simulator, a technique used to collect data required for the drug labelling, when pre- and early clinical studies indicate that a drug may cause somnolence or impair cognition.
It assessed 31 healthy, fully licensed drivers, 15 male and 16 female aged between 21 and 58 years, and the participants consumed either CannEpil or a placebo. At 90 minutes post-treatment, the participants completed a 40 minute “highway” drive using a driving simulator which was used to assess performance outcomes of deviation of lateral position, the standard deviation of speed, and steering variability.
Mood states and sedation levels were assessed by the Bond-Lader Visual Analogue Scale and Profile of Mood States which were administered prior to and/or following the driving task.
Currently, recreational cannabis consumption is implicated in as many as 13 per cent of drivers involved in fatal road traffic accidents in Australia. However, the direct effect of medicinal cannabis use on driving performance remains unclear.
Legislative changes in Australia permit the regulated consumption of cannabinoid-based products for therapeutic purposes, but currently, there is no standard clinical or legal guidance outlining when it is safe to drive after its use, and a positive roadside saliva test for THC may lead to criminal convictions irrespective of prescribed use.
Between 300 to 400 patients have been prescribed CannEpil across Australia and the Republic of Ireland monthly over the past two years.
MGC Pharma hopes that standardised assessment of performance decrements, including the findings of this Trial, will inform policy guidelines concerning the responsible use of medicinal cannabis products.
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