A drug derived from marijuana has been the first to be approved by the U.S. Food and Drug Administration for the treatment epilepsy.
The drug, which will be marketed under the name Epidiolex, will specifically seek to treat two serious forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. These syndromes are known to begin in childhood and persist in adulthood.
Epidiolex is made from purified cannabidiol (CBD), a compound present in the cannabis plant. CBD is known to have medicinal effects, however, it does not exert the mind-altering high that results from THC, the primary psychoactive component of marijuana.
"This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies," explains FDA Commissioner Scott Gottlieb.
A few states have approved CBD oil in the treatment of intractable epilepsy or seizure disorders.
"Our biggest concerns with the artisanal [or supplement] versions of CBD were related to the consistency," Carson says. "We can't guarantee the consistency."
Carson believes he will likely prescribe Epidiolex in the future. "I'm always excited about the potential for a new therapy that has been well-studied and has a great potential for benefit," says Carson.
Multiple investigators are examining the efficacy of CBD in the treatment of psychiatric conditions. For example, a clinical study is now underway to examine whether CBD can effectively treat post-traumatic stress disorder and alcohol use disorder. Additionally, another clinical study will test whether CBD could be a potential treatment to help prevent relapse in opioid abusers.
Such approval of Epidiolex will help open the doors to more studies on CBD, which will lift a regulatory hurdle. As of now, the Drug Enforcement Administration placed CBD in the heroin and LSD category as a Schedule 1 substance which mean that these drugs have no medical use potential and only a high abuse substance.
According to Dr. Douglas Throckmorton, deputy director of regulatory programs at the FDA's Center for Drug Evaluation and Research , when CBD is approved as a medical use drug- the DEA will change its classification.
"The DEA will need to make a different scheduling decision for CBD...because it now has an accepted medical use," explains Throckmorton.
