Governor outlines plans for clinical trials at Georgia Regents University for children with epileptic disorders
Gov. Nathan Deal today plotted a path forward for the safe and legal use of cannabis oil by Georgia children suffering from epileptic disorders. The governor also announced that he and the Department of Human Services will launch pilot projects for public-private partnerships in the state’s foster care system.
Deal has consulted with the federal Food and Drug Administration on how the state can begin legal clinical trials with cannabis oil products at Georgia Regents University Augusta.
“So far we have identified two tracks worthy of pursuit,” Deal said. “Our most promising solution involves pairing GRU with a private pharmaceutical company that has developed a purified liquid cannabinoid currently in the FDA testing phase. The product contains no THC, which is the component in marijuana that intoxicates a user. The university would create a well-designed trial for children with epileptic disorders, and in order to serve as many children as we can, we would like to pursue a statewide investigational new drug program through a multicenter study that would allow GRU to partner with other research facilities across the state. We have talked with the pharmaceutical company to gauge interest, and the company is willing to continue those initial talks.
“Georgia will also possibly pursue a second clinical trial at GRU that would use cannabidiol oil obtained from cannabis product grown by the National Institute on Drug Abuse at its farm located at the University of Mississippi. This road would perhaps take more time because it would require GRU to work through an approval process with NIDA and the FDA.
“We do not see these options as mutually exclusive, and we’re looking to move forward on both options at this time.
“The General Assembly this year gave serious consideration to legislation that would pave the way for patients in need of cannabis to receive it safely and legally. An issue that could have triggered controversy instead yielded teamwork and a commitment to see this through, as legislators – and I as well – learned the stories of these brave families who are desperately seeking relief for their children’s debilitating conditions. The legislation earned significant levels of support in both houses and in both parties but didn’t make into any bills that reached my desk.
“Even if the legislation had passed, we still would need to take these steps, so we haven’t lost any time. As we progress, we’ll determine if the General Assembly needs to take additional action next year.”
Georgia Regents University expressed its excitement about the clinical trials.
“As the state’s academic health center encompassing a 154-bed children’s hospital, we have a responsibility to address the needs of families whose children are suffering,” said Georgia Regents University President Ricardo Azziz. “We are appreciative of Gov. Nathan Deal for this vote of confidence and look forward to working with the state to establish clinical trials to research the benefits of treating epilepsy and other neurological conditions with cannabidiol oil."