GW Pharmaceutical’s latest cannabis-derived drug is to be made available to a small number of children in Australia. Phase 4 trials are due to begin in New South Wales in March, with a handful of kids with drug-resistant epilepsy being given the chance to try Epidiolex, a CBD-based drug which has shown promise as an effective anti-convulsant.
The news comes after Pru Goward, the New South Wales Minister for Medical Research, personally visited GW Pharmaceuticals in London in an attempt to convince them to hold the latest round of trials in the Australian state.
It also comes three months after the Federal Government of Australia announced that it will legalise the production of medical cannabis in the country. Their plan is to allow individual states to decide whether or not they want to allow cannabis to be grown there, much like they do in the USA. Except unlike in America, those states that decide to take up the offer of legal, regulated production will not be breaking Federal law. Australia’s main opposition party are in favour of the move, but insist that any rollout of cannabis production should be done nationwide, to ensure access for everybody who needs it.
If the Epidiolex trial is successful, it is expected to be available in pharmacies in roughly three years. Because of this delay, it will be interesting to see which becomes available to patients first: Raw medical cannabis, or Epidiolex. Given that the supposed appeal of GW’s drug (according to most reports from Australia) is its lack of psychoactivity, one presumes that this would have played a significant role in the decision to allow it to be trialled on children. If it is shown to be effective, as is expected, will those same children be forced to stop taking it in the time between the trial ending and its appearance on pharmacy shelves? And will the government allow ‘medical cannabis’ to be prescribed to children, as opposed to a ‘cannabis-based drug’, which is essentially the same thing. These are all questions and problems which will have to be overcome if the scheme is to be successful.
As well as the Epidiolex trial, two other trials of GW produced drugs have also been announced. The first of these is a Phase 2 trial of another anti-convulsant cannabinoid, cannabidivarin (CBDV). Together with the Epidiolex trial, these two are the basis of a $3.5million commitment from the Australian government to “explore the use of cannabis products in providing relief for children with severe drug-resistant epilepsy”. Part of this commitment is a new relationship between Australia and GW, which includes a provision for New South Wales to host future clinical trials of GW products. One of these ‘future trials’ is likely to be of a drug designed to treat the side effects of chemotherapy, details of which are expected to be announced later this year.
Whilst all of this is without doubt great news for the parents of children suffering horribly from severe epilepsy, there are certain causes for concern. As mentioned above, those parents, and those suffering children, are likely to have to wait another three years before Epidiolex is widely available. In the meantime, unless the rollout of medical cannabis production happens quickly, and isn’t blunted by a lack of availability for children, parents will have to make the same difficult choices as parents in their position in most of the world: Wait for a ‘medicalised’, standardised version of a drug they know could help, or become criminals by taking matters into their own hands and refusing to wait. People have already been forced into that position far too many times and for far too long. Hopefully, in Australia at least, they’ll be able to act quickly to make sure no one ever has to make that choice again.
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