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FDA Approves Marijuana-Based Epilepsy Drug For Use On Kids In Clinical Trials
Federal regulators have approved two clinical studies testing whether a marijuana-based epilepsy drug may help prevent seizures among epileptic children.
In San Francisco and New York City, the physician-led pediatric studies will assess the viability of a purified cannabidiol as an anti-seizure treatment among patients with various forms of epilepsy. Although both studies will enroll 25 patients initially, the U.S. Food and Drug Administration (FDA) may approve more as the studies progress.
Drs. Roberta Cilio and Orrin Devinsky, of the University of California, San Francisco and New York University, respectively, will investigate the use of Epidiolex, a 98 percent purified cannabidiol drug manufactured by GW Pharmaceuticals, of the United Kingdom. Cilio will also conduct two individual studies of the drug.
Geoffrey Guy, chairman of the pharmaceutical company, told reporters that the purified drug contains no tetrahydrocannabinol (THC), the psychotropic ingredient in marijuana causing the recreational high. “Our definition of pure is no THC,” Guy said, adding that clinical study would help provide “better understanding and experience in what cannabidiol does in these different children groups, what benefit we can see, and how the results can best be measured.”
In San Francisco and New York City, the physician-led pediatric studies will assess the viability of a purified cannabidiol as an anti-seizure treatment among patients with various forms of epilepsy. Although both studies will enroll 25 patients initially, the U.S. Food and Drug Administration (FDA) may approve more as the studies progress.
Drs. Roberta Cilio and Orrin Devinsky, of the University of California, San Francisco and New York University, respectively, will investigate the use of Epidiolex, a 98 percent purified cannabidiol drug manufactured by GW Pharmaceuticals, of the United Kingdom. Cilio will also conduct two individual studies of the drug.
Geoffrey Guy, chairman of the pharmaceutical company, told reporters that the purified drug contains no tetrahydrocannabinol (THC), the psychotropic ingredient in marijuana causing the recreational high. “Our definition of pure is no THC,” Guy said, adding that clinical study would help provide “better understanding and experience in what cannabidiol does in these different children groups, what benefit we can see, and how the results can best be measured.”
http://www.medicaldaily.com/fda-approves-marijuana-based-epilepsy-drug-use-kids-clinical-trials-261998
Medical researchers believe cannabidiol provides therapeutic benefit by interacting with receptors in the brain and spinal cord. During the past couple of decades, investigators have discovered two different types of cannabinoid receptors in the brain, spinal cord, and peripheral tissues, including immune tissues. Scientists say the cannabinoid system interacts with many other neurotransmitter/neuromodulator systems for a reach that extends nearly throughout the body.
Moreover, researchers say current knowledge of the cannabinoid system suggests the existence of other cannabinoid receptors yet to be discovered.
Moreover, researchers say current knowledge of the cannabinoid system suggests the existence of other cannabinoid receptors yet to be discovered.
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