The Drug Enforcement Administration has rescheduled the cannabidiol medication Epidiolex, allowing manufacturer GW Pharmaceuticals to begin selling the drug in the United States. The DEA did not, however, reschedule CBD itself nor other products made with the cannabinoid. Epidiolex is the first medication derived directly from cannabis to be approved by the Food and Drug Administration.
The DEA placed Epidiolex in Schedule 5, the least restrictive class under the Controlled Substances Act, indicating the drug has an accepted medical use and a low potential for abuse. Cannabidiol and other CBD formulations continue to be listed under Schedule 1, a classification ostensibly reserved for drugs with no medical value and a high potential for abuse.
New Drug Approved In June
In June, Epidiolex was approved by the FDA as a treatment for Lennox-Gastaut syndrome (LGS) and Dravet syndrome. The two debilitating forms of childhood epilepsy can cause dozens or even hundreds of seizures per day and often cannot be treated successfully with other medications.
Justin Gover, the CEO of GW Pharmaceuticals, said in a press release that the action by the DEA will allow patients access to an entirely new class of epilepsy drugs.
“We are pleased that the DEA has placed EPIDIOLEX in the lowest restriction Schedule, because it will help ensure that patients with LGS and Dravet syndrome, two of the most debilitating forms of epilepsy, can access this important new treatment option through their physicians,” said Gover.
CBD Drug Will Be Available Soon
GW Pharmaceuticals is now finalizing the packaging for Epidiolex, which should be available to be prescribed to patients in less than two months.
“With this final step in the regulatory process completed, we are working hard to make EPIDIOLEX available within the next six weeks as we know there is excitement for a standardized version of cannabidiol that has undergone the rigor of controlled clinical trials and been approved by the FDA,” Gover said.
The Epilepsy Foundation, an advocacy and resource organization, applauded the DEA action in a press release.
“We are pleased to hear that the U.S. Drug Enforcement Administration (DEA) placed Epidiolex® at Schedule V in line with the U.S. Food & Drug Administration’s (FDA) scheduling recommendation,” the group wrote. “People with epilepsy who are unable to obtain seizure control with existing treatments are at a higher risk of accident, injury, hospitalization, and even death. The DEA’s rescheduling of Epidiolex,® the first ever drug derived from cannabidiol (CBD) approved to treat Dravet and Lennox-Gastaut syndromes (LGS), is a tremendous milestone for some of these most vulnerable individuals who now may have access and hope of gaining better seizure control.”
Although Epidiolex has only been approved by the FDA to treat Dravet syndrome and LGS, so-called off-label use of drugs for other conditions is legal and a common practice with other medications. The price of the new drug may be prohibitive for some patients that need it, however. In August, GW Pharmaceuticals announced that the average annual cost of Epidiolex would come to about $32,500 per year, although most patients with health insurance would pay a fraction of that figure.
CBD Still Schedule 1
Despite classifying Epidiolex as a Class 5 substance, the DEA continues the Schedule designation for cannabis and cannabinoids. With that decision, future CBD medications will also have to go through the expensive and time-consuming process to receive FDA approval. Tim McGraw, the CEO of cannabis real estate development company Canna-Hub, told High Times that the ruling could stifle growth in the industry.
“This locks out any other players not considered to be ‘big pharma.’ On one hand, they approved the substance as non-addictive with medicinal properties, while on the other hand, they continue to classify THC and CBD molecules in “non-approved” products as schedule 1 with other drugs such as heroin. There seems to be a discrepancy within the US government.”
Dr. Stuart Titus, the CEO of Medical Marijuana, Inc., agreed, adding that the ruling could spur change.
“This decision shows that the federal government will go to the end of the earth to support their hypocrisy on cannabis, including CBD, ” Titus said. “This may provide the tipping point with public opinion to get further federal legislation passed on cannabis and hemp CBD.”
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