19 September 2016

A group of children in the Hunter New England region have begun receiving doses of pharmaceutical-grade, cannabis-derived medicine to treat severe, treatment-resistant epilepsy under the NSW Government’s Compassionate Access Scheme for Epidiolex®, led by Sydney Children’s Hospitals Network.

The lead trial researcher Dr John Lawson, from Sydney Children’s Hospital, Randwick, said about 12 children with severe epilepsy will participate in the Compassionate Access Scheme for Epidiolex® at John Hunter Children’s Hospital, as part of a wider trial involving up to 40 children.

The Scheme, which is part of the NSW Government’s $21 million commitment to explore the therapeutic use of medicinal cannabis, occurred as a result of a memorandum of understanding with GW Pharmaceuticals.

“This is an important first step in exploring the clinical use of cannabis-derived medicine for the treatment of severe childhood epilepsy,” said Dr Lawson.

“The 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.

“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.

“NSW is leading the way in exploring the use of safe and effective cannabis-based treatment options for children suffering from severe, treatment-resistant epilepsy. This work includes world-first research and clinical trials in this area,” he said.

Epidiolex® is an oral pharmaceutical formulation of pure cannabidiol (CBD), a non-psychoactive component of the cannabis plant, developed by GW Pharmaceuticals. It is currently being investigated for its effect in treatment-resistant epilepsy in children.

Epidiolex® supplied by GW Pharmaceuticals under the Compassionate Access Scheme is reserved for those children who have exhausted conventional treatment options and whose paediatric neurologist considers that they meet agreed criteria. Currently, because it is an experimental medication, Epidiolex® has not been considered by the Therapeutic Goods Administration (TGA) for routine use in Australia.

For more information on the Compassionate Access Scheme for Epidiolex®, please refer to www.medicinalcannabis.nsw.gov.au/clinical-trials/pediatric-epilepsy-trial ​​​​​​​​

Page Updated: Monday 19 September 2016