Albany, NY - June 3, 2014 - Governor Andrew M. Cuomo today announced an agreement between New York State and GW Pharmaceuticals to develop clinical trials using an active ingredient derived from the marijuana plant to help treat children diagnosed with epilepsy who suffer from seizures and other medical complications. The children who will participate in these trials are those whose medical conditions have not been successfully treated by other methods, and New York will be the second state in the nation to initiate trials for the extract, known as cannabidiol (CBD).
"No child should be forced to live with the heartbreaking effects of medication-resistant epilepsy," Governor Cuomo said. "Young New Yorkers battling these diseases deserve treatments that work for them, and by investigating the merits of cannabidiol we are pushing the boundaries of modern medicine and working to fundamentally improve the quality of life for those children. I am very hopeful that this research collaboration will grow our understanding of these types of medications and ultimately help New Yorkers lead better lives."
The New York State Department of Health (DOH) will take the lead in developing the clinical trial for submission to the U.S. Food and Drug Administration, while GW Pharmaceuticals will provide consultative advice and commit personnel and other resources to the partnership, including a supply of Epidiolex©, their CBD product. Designed to be conducted at New York-based hospitals, universities and medical colleges, the clinical trial will address a critical healthcare priority while expanding the scientific community’s understanding of potential treatments for children with medication-resistant epilepsies.
Dr. Geoffrey Guy, Chairman of GW Pharmaceuticals, said, “We are pleased to be partnering with the State of New York in this groundbreaking program designed to establish a scientific foundation that expands the understanding of how CBD works in children with treatment-resistant epilepsies. This collaboration with the State of New York builds on the foundation established by our relationship with New York University’s Langone Medical Center where 60 children are already authorized by the FDA to receive Epidiolex.”
About GW Pharmaceuticals
GW Pharmaceuticals is a world leader in the development of prescription cannabinoid medicines, and conducts scientific research in accordance with U.S. federal law with permission from the U.S. Food & Drug Administration (FDA) and the U.S. Drug Enforcement Administration (DEA). The FDA has already authorized, physician-sponsored Investigational New Drug (IND) programs with Epidiolex at 12 sites around the U.S involving over 300 children. In parallel, GW is progressing a company-sponsored formal development program for Epidiolex that is focused on the treatment of two rare and severe forms of childhood epilepsy, Dravet syndrome and Lennox-Gastaut syndrome (LGS).