Pharmaceutical cannabidiol is being used to treat children with severe, treatment-resistant epilepsy as part of three wider trials
A few children with severe, treatment-resistant epilepsy have already begun treatment at John Hunter Children’s Hospital in the Hunter New England region of NSW, confirms a state government spokesperson.
During the course of the trial, up to 12 children will receive doses of a pharmaceutical-grade, cannabis-derived medicine called Epidiolex to treat their condition.
The children will access the medicine through the Compassionate Access Scheme for Epidiolex at John Hunter Children’s Hospital, as part of a wider trial of the drug involving up to 40 children.
“The [Compassionate Access] Scheme will see some of the sickest children in NSW – who have not responded to available epilepsy drugs and treatments – gain access to a regulated pharmaceutical supply of the promising medicine, cannabidiol, at an earlier date than was expected, and before it is accessible in many other countries,” says lead trial researcher Dr John Lawson, from Sydney Children’s Hospital in Randwick, NSW.
“These children suffer from such severe, treatment-resistant epilepsy – some with hundreds of seizures a day – that they are too sick to take part in clinical trials. This Scheme fills that gap in the hope of providing some relief to them and their families,” he says.
Epidiolex is an oral pharmaceutical formulation of pure cannabidiol (CBD), a non-psychoactive component of the cannabis plant, which is manufactured by British company GW Pharmaceuticals.
Currently, because it is an experimental medication, Epidiolex has not been considered by the TGA for routine use in Australia.
A palliative care trial is also set to enrol patients in the coming months. This trial will use a vapourised cannabis flower bud to compare tetrahydrocannabinol (THC) alone, or THC combined with cannabidiol (CBD), and placebo, in their ability to improve appetite in terminally ill cancer patients.
The first part will be conducted at the Calvary Mater Newcastle Hospital and Sacred Heart Health Service in Sydney, while the second part of the trial will enrol a larger number of patients in major hospitals across NSW that are yet to be confirmed.
Meanwhile, a trial for chemotherapy patients is progressing through ethics and regulatory approvals and is expected to being towards the end of this year, confirms the NSW Health Department. This research will aim to treat chemotherapy-induced nausea and vomiting using oral cannabis-derived capsules containing THC and CBD, developed and supplied by Canadian medicinal cannabis company Tilray.
Doctors in NSW are also now able to apply to prescribe a broader range of cannabis-based medicines as a result of state regulatory changes, the state government announced in July.
“This change increases the options available for doctors as it means a broader range of cannabis-based medicines can be prescribed – while we continue our evidence-based research looking further into the role medicinal cannabis can play,” says Premier Mike Baird.