Driver, surprise me: MGC Pharma to test epilepsy drug on driving performance
Health & Biotech
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Special Report: The Australian clinical trial ethics body has signed off on a proposal from MGC Pharma to assess the effects of its epilepsy drug on driver performance.
And now the company has received approval from the Human Research Ethics Committee — which must sign off on all clinical trials before they can proceed — to conduct a controlled trial on its effects on driver competency and performance.
Data from the trial, if successful, will then form part of the application to be submitted to the Australian Therapeutic Goods Administration (TGA) and the European Medicines Agency (EMA) for product registration.
It will be one of the first trials globally to assess the impact of medicinal cannabis products on driving competency.
The hope is that it will allow patients taking CannEpil and other similar products to still drive while under treatment. Australian law currently prohibits patients consuming medicinal cannabis from driving.
The trial will involve 30 healthy individuals aged between 21 and 60, with half given CannEpil and half a placebo.
This will be followed by driving performance tests in a simulator at Swinburne University of Technology, in conjunction with Cannvalate, an Australian distributor of CannEpil.
Once enrolment is completed MGC expects results from the trial as early as July next year. Roby Zomer, co-founder and managing director of MGC, is hoping the trial will increase uptake of medicinal cannabis.
“We are hoping this trial will clearly demonstrate that it is safe to drive while on CannEpil,” he says.
“It has been documented that a key reason for individuals in Australia to decline cannabis products for medical purposes that may benefit them is that it would inhibit them from driving.”