The FDA approval of Epidiolex on Monday, a cannabis-derived medication to treat epilepsy sufferers, made breaking headlines.
The move made many speculate that following the FDA approval of Epidiolex, the US federal government will soften up and change its stance on marijuana, especially amid the continuous trend happening in the United States in terms of legalizing either medical or recreational marijuana.
However, observers don’t think that’s the case on the backdrop that the FDA itself said Epidiolex approval, an oral solution approved for the treatment of two rare forms of epilepsy, doesn’t mean marijuana is finally going to be accepted.
FDA Commissioner Scott Gottlieb said while the approval of Epidiolex “demonstrates that advancing sound scientific research to investigate ingredients derived from marijuana can lead to important therapies” and that “this new treatment provides new options for patients,” he said:
“It’s also important to note that this is not an approval of marijuana or all of its components.”
Not the first
Contrary to what has been reported, the CBD-derived Epidiolex is not the first marijuana-based medication approved by the FDA.
CBD is the component found in cannabis that gives the soothing and calming effect, while THC, is marijuana’s natural psychoactive ingredient that gives the feeling of “high.”
In 1985, a THC derivative, most commonly prescribed under the brand name Marinol, received an approval by the FDA. Marinol is used to combat nausea associated with cancer treatments and to help increase the appetite of people with AIDS, Healthline reported.
Dr. Jordan Tishler, a Harvard-educated physician as well as president and chief executive officer of the Association of Cannabis Specialists, told Healthline that Marinol’s approval didn’t change the federal government’s perception of marijuana in the 1980s.
“The federal government’s position on cannabis is based on a fiction invented at the time of the enactment of the CSA (in 1971). They have willfully disregarded any and all scientific data since then,” Tishler told Healthline.
“I think the federal government may change its view on cannabis in the next few years, but it won’t be driven by this product nor by the FDA itself.”
Stephanie Yin, an analyst at Informa Pharma Intelligence, told The Verge that the FDA already approved two nausea drugs — dronabinol and nabilone — that use synthetic versions of THC.
Yin said Epidiolex approval doesn’t mean that cannabis as a drug will be removed from Schedule I. However, Yin said the DEA will most likely reclassify CBD in the next 90 days.
She said most likely CBD will be changed to Schedule IV or Schedule V, which are schedules that include other anti-seizure medications and anxiety drugs like Xanax and Klonopin.
However, there is always hope in the horizon.
“Cannabis policy is changing in the U.S. and will soon lead to legalization on a federal level,” Sanford Wolgel, PhD, former chief science officer at the Chicago-based Cannabistry Labs, told Healthline. “When this happens, it will allow for much more academic and medical research of both CBD and cannabis.”
After Epidiolex approval, Oklahoma voted to legalize medical marijuana the day after.
Now with Oklahoma becoming the 30th US state to legalize medical marijuana, in addition to nine other states where recreational cannabis is already legal, the trend is not stopping.
“The time to decriminalize marijuana is now,” he said.