In June of 2018, the FDA approved, for the first time, a cannabis based drug. Epidiolex, is a CBD drug used to treat Dravet Syndrome. Dravet Syndrome is a devastating form of lifelong epilepsy that reveals itself in infancy. While there are no cures for Dravet Syndrome, Epidiolex has been found to drastically limit the number of seizures in those with the condition. According to the FDA, “Epidiolex’s effectiveness was studied in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome.”
What is Epidiolex?
The drug, which has been approved for use in those aged two years and older, consists of extracted CBD and no THC. CBD is the non-psychoactive and anti-inflammatory compound of cannabis and THC is the psychoactive compound that causes the consumer to feel a “high” when using cannabis. What makes CBD such an enticing medicinal compound, especially for children, is that there are so few side effects. The FDA found that the only main side effects of Epidiolex were occasional “sleepiness, sedation and lethargy.”
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The DEA approved GW’s Epidiolex in June, but since it is derived from cannabidiol, or CBD, from marijuana GW waited to see if the DEA would reschedule the drug, which they did today. GW’s Epiodiolex will be classified as a Schedule 5 controlled substance. Other medications that have a Schedule 5 classification include cough syrups containing codeine. Marijuana is still classified as a Schedule 1 Drug. By definition means that cannabis has no medicinal value and a high potential for abuse. The DEA did not reschedule or include an other CBD cannabis or hemp products. Comments? #marijuana #cannabis #cbd #cannabiscommunity #cannabidiol #bigpharma #medicalmarijuana411
Why the DEA Approval Is Important
While the first important step in Epidiolex’s approval process was receiving FDA approval the expectedly tougher aspect was receiving the approval of the Drug Enforcement Agency. The DEA still considers cannabis and any of its related compounds as Schedule 1 drugs. In order to approve Epidiolex, many assumed that the DEA would have to reschedule CBD. However, according to Business Insider, “Instead of rescheduling CBD, the agency chose to reschedule drugs containing CBD that the FDA has already approved; those drugs will now be classified as Schedule 5. But at the moment, the only drug that fits the description is Epidiolex.”
The DEA ruling does allow for future CBD-related drugs to be approved only after the FDA approves them. The DEA ruling provides a window into the possible future of cannabis drugs and certainly gives hope to many in the cannabis industry that the DEA is finally beginning to loosen their rules on medicinal cannabis.