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World first for NSW medical cannabis trials for children with epilepsy

28 October 2015
An agreement for a world first research program for cannabis-based medicines in children with severe drug resistant childhood epilepsy has been signed between the NSW Government and GW Pharmaceuticals.
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A Memorandum of Understanding (MOU) was signed as part of the government's $21 million funding package to support medicinal cannabis reforms in NSW.

NSW Premier Mike Baird said the groundbreaking trials confirm NSW’s position as a world leader on medicinal cannabis research which will give vulnerable children access to innovative and advanced drugs.

“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,” Mr Baird said.

The government will provide $3.5 million to the Sydney Children’s Hospitals Network to lead the world first phase 2 clinical trial of GW’s product containing the cannabinoid cannibidivarian (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 effects associated with herbal cannabis.

The MOU will also facilitate:

• 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 NSW to host additional phase 3 clinical trials of Epidiolex® in children with treatment-resistant epilepsy

• A phase 4 clinical trial of Epidiolex® based on phase 3 studies

The partnership between the NSW Government and GW Pharmaceuticals also means NSW could host groundbreaking additional trials in the future.

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