Can cannabis-based medicines change the future of children with epilepsy?

New South Premier Mike Baird and Minister for Medical Research Pru Goward announced on Tuesday the signing of a Memorandum of Understanding (MOU) between the New South Wales Government and GW Pharmaceuticals.

The $21 million dollar commitment to support medicinal cannabis reforms will progress a major new research program for cannabis-based medicines in children with severe, drug resistant childhood epilepsy.

“This confirms New South Wales’ position as a world leader on medicinal cannabis and demonstrates the determination of our Government to ensure we secure these ground breaking trials,” Mr Baird said.

“Our research and development is driven by compassion for those suffering so we hope these initiatives will bring relief to many children and their loved ones.”

The MOU with GW, a world leader in the research and development of novel cannabis-based prescription medicines, with more than 17 years of cannabinoid research experience, will facilitate:

• A world first, phase 2 clinical trial in children for GW’s novel product containing the cannabinoid cannibidivarin (CBDV);
• A compassionate access scheme for Epidiolex®, GW’s product containing cannabidiol (CBD) which is currently in late stage trials in childhood epilepsy in the United States;
• Provision for New South Wales to host additional phase 3 clinical trials in children with treatment-resistant epilepsy; and
• And a phase 4 clinical trial of Epidiolex® based on phase 3 studies.

The New South Wales Government is providing $3.5 million to the Sydney Children’s Hospital Network to lead the world first, phase 2 clinical trial of CBDV in children, commencing in 2016.

“Pre-Clinical studies have shown that CBDV has significant promise as an anti-epileptic agent,” Dr John Lawson, Sydney Children’s Hospital Network spokesperson said.

What is CBDV?

CBDV is a molecule in the cannabis plant that has shown promising results as an anti-convulsant, and for which GW Pharmaceuticals already has phase 1 clinical trial results in adults.

CBDV does not produce the psychoactive effect associated with herbal cannabis.

"The phase 1 testing was carried out in healthy adults with no significant side effects," said GW CEO Justin Glover. "We're now ready to progress to phase 2 in children and have chosen to do this in New South Wales."

The goal of the trials into both CBDV and Epidiolex ® is to gather location medication safety data to support an application to the Australian Therapeutic Goods Administration to make the product more widely available, should it be proven to be useful.

 “Our most vulnerable children will have access to these innovating and advanced drugs,” Ms Goward said.

For further information click here for the joint press release from NSW Premier Mike Baird and the NSW Minister for Medical Research Pru Goward.

Mike Cullen has recently returned to Akolade after a period as the conference producer for one of Australia's leading economic think tanks. Mike began working in the conference industry in 2007 after looking for a career change from the high pressured world of inbound customer service. Mike has worked for some of the most well known conference and media companies in the B2B space and in his spare time is working on his first novel in a planned Epic Fantasy trilogy.