GW Pharmaceuticals and the Government of New South Wales Announce Clinical Trial for Children with Epilepsy

GW Pharmaceuticals plc and the Government of New South Wales (NSW) Australia, have signed a Memorandum of Understanding (MOU,) to progress a research program for Epidiolex® (cannabidiol or CBD) and cannabidivarin (CBDV) in children with severe, drug resistant childhood epilepsy.

“GW is pleased to have been able to respond to the needs of the New South Wales government and its citizens by establishing this research program for cannabinoid-based medicines in children with treatment resistant epilepsy,” said Justin Gover, GW’s Chief Executive Officer. “As part of this research partnership, GW expects to advance clinical trials in Australia for both Epidiolex and our earlier stage pipeline product CBDV.”

“This confirms NSW’s position as a world leader in cannabinoid research and demonstrates the determination of our Government to ensure we secure these groundbreaking trials,” stated NSW Premier Mike Baird. “Our research and development is driven by compassion for those suffering so we hope that these initiatives will bring relief to many children and their loved ones.”

The NSW Government is providing $3.5 million to the Sydney Children's Hospitals Network to lead the Phase 2 clinical trial of CBDV in children, which is expected to commence in 2016. The agreement also delivers a compassionate access program for Epidiolex for a small number of children who are too sick to participate in a clinical trial, due to the unrelenting nature of their epilepsy. Like CBD, CBDV does not produce the psychoactive effects associated with herbal cannabis. The package is supported through the NSW Government’s $21 million commitment to support medicinal cannabis reforms.