Two clinical trials aimed at treating children with medication-resistant epilepsy with cannabidiol have been approved at Georgia Regents University. The first - a two-person compassionate use protocol that received authorization from both the Drug Enforcement Agency and the U.S. Food and Drug Administration - begins December 30gh at Children's Hospital of Georgia. The second will allow for an expanded 50-person trial, initiated at GRU with planned expansion to Savannah and Atlanta.
The state, along with GW Pharmaceuticals, and officials at GRU have been working together since May to begin a study with GW's investigational cannabidiol (CBD) product Epidiolex®, which has promising data for difficult to treat childhood epilepsies.
Georgia Governor Nathan Deal announced in April his support for clinical research that would investigate the use of CBD, a non-psychoactive component of the cannabis plant, and develop rigorous data that will inform and expand the scientific community's understanding of potential treatments.
"No one with a heart could hear the stories of these children and their parents and not want to exhaust every possibility to provide them with the treatment they need to combat this debilitating condition," said Gov. Nathan Deal. "I believe this initiative can have a meaningful and positive impact on the health of suffering children. Georgians have expressed overwhelming support for these endeavors, and I'm committed to finding solutions for these brave families."
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 FDA and DEA. The FDA has already authorized physician-sponsored Investigational New Drug programs with Epidiolex at 20 sites around the U.S involving over 400 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.
"We are pleased to be partnering with the State of Georgia and Georgia Regents University in response to the significant unmet needs of children with treatment-resistant epilepsies by providing physicians with access to our medicine Epidiolex," said Dr. Geoffrey Guy, Chairman of GW Pharmaceuticals. "In parallel with this GRU program, GW is advancing a formal clinical trial program with the FDA and has commenced placebo-controlled clinical trials designed to gain approval for Epidiolex as a prescription medicine."
"As the state's public academic medical center, we should be on the leading edge in the treatment of these disorders," said GRU President Dr. Ricardo Azziz. "Georgia's children should not have to go elsewhere. We have a responsibility to bring the medicine of tomorrow to patient care today. We are excited to partner with GW Pharmaceuticals to study investigational cannabidiol and potentially change the lives of children with medication-resistant epilepsies."