The U.S. Food and Drug Administration has approved a marijuana-derived drug for the treatment of two rare and serious forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, that begin in childhood but can persist in adulthood.
The drug is made from purified cannabidiol, or CBD, a compound found in the cannabis plant. The drug will be marketed under the brand name Epidiolex.
CBD has medicinal effects, but it does not cause the mind-altering high that comes from THC, the primary psychoactive component of marijuana.
The FDA says this is the first drug approved in the U.S. that contains a purified substance derived from marijuana. The agency has previously approved drugs made from synthetic versions of THC and other marijuana constituents.
…Several researchers are studying the potential of CBD to treat psychiatric conditions. For instance, a clinical trial is underway to test whether CBD can be an effective treatment for people with post-traumatic stress disorder and alcohol use disorder. Another clinical trial will determine whether CBD could help prevent relapse in opioid abusers.
The approval of Epidiolex may help open the door to more CBD research, as it helps to lift one regulatory hurdle. Until now, the Drug Enforcement Administration has classified CBD as a Schedule 1 substance. Like other drugs in this category, which include heroin and LSD, these drugs are considered to have no medical use and a high potential for abuse.
But now, with the approval of a CBD drug, the DEA will change this, according to Dr. Douglas Throckmorton, deputy director of regulatory programs at the FDA’s Center for Drug Evaluation and Research,
“The DEA will need to make a different scheduling decision for CBD…because it now has an accepted medical use,” he said during a conference call with reporters.
He said the reclassification is underway now.