Under ordinary
circumstances, most physicians wouldn't know much about Epidiolex, an
anti-seizure medicine that helps with two rare forms of epilepsy.
But Epidiolex
is the country's first approved medication to contain cannabidiol (CBD), a
chemical component of the Cannabis sativa plants — better known as marijuana.
In the past, all marijuana-based substances have been listed by the U.S. Drug
Enforcement Administration (DEA) as Schedule I drugs — those that have a high
potential for abuse and the potential to create severe psychological or
physical dependence.
But all that changed
in September when the DEA issued an order listing all drugs approved by the
U.S. Food and Drug Administration (FDA) that contain CBD but no more than 0.1
percent of the chief psychoactive agent in cannabis as Schedule V drugs — those
with the least potential for abuse.
So far,
Epidiolex is the only medication that fits that description.
The
introduction of Epidiolex, which is produced by Greenwich Biosciences, is part
of a larger movement toward using CBD in medicine.
CBD has been touted as helping with a variety of
medical problems, including epilepsy, post-traumatic stress disorder, and
multiple sclerosis.
In 2015, the
Texas Legislature passed the Compassionate
Use Act, which legalized the sale of CBD in Texas just for
one narrow medical condition: refractory epilepsy. The Texas Medical Association at the time testified in favor of
further study on the use of marijuana products as medicine. The new
law allowed three Texas-based dispensaries to start producing CBD oils for sale
to epilepsy patients. The first sales took place early in 2018.
Epidiolex,
which the FDA approved in June 2018, is a direct competitor to the oils
produced by these dispensaries. Unlike CBD oil, Epidiolex is both FDA-approved
and is expected to be covered by most health insurance plans. Nevertheless,
Morris Denton, the CEO of Compassionate Cultivation, one of the Texas dispensaries,
told Texas Medicine Today earlier
this year that the success of Epidiolex is likely to help his business long
term.
"From my perspective, I’m rooting for [Epidiolex],” Mr.
Denton said. “Because if the FDA says, sure, CBD has medicinal value, then CBD
has medicinal value for not just epilepsy, but a variety of other medical
conditions, as well.”