GW Pharma’s epilepsy medication was awarded Schedule V status by the feds, and is now expected to be available to patients before the year is over.
Epidiolex, the first cannabis-derived CBD medication approved by the FDA for use in the treatment of epileptic seizures, was awarded Schedule V status — a classification that contains drugs with both an accepted medical value and a particularly low potential for abuse.
The scheduling adjustment will not be reciprocated for other refined cannabis CBD products sold in state-legal medical or recreational marijuana markets, hemp-derived CBD extracts, or any other type of cannabis flower or compound. But following Epidiolex’s groundbreaking FDA approval in June, the DEA decision is another significant step forward, and will allow patients to access the anti-seizure drug through a physician’s prescription.
“DEA will continue to support sound and scientific research that promotes legitimate therapeutic uses for FDA-approved constituent components of cannabis, consistent with federal law,” Acting DEA Administrator Uttam Dhillon said in press release. “DEA is committed to continuing to work with our federal partners to seek ways to make the process for research more efficient and effective.”
According to officials at GW Pharmaceuticals, the producers of Epidiolex, the Schedule V classification was a best case scenario for the soon-to-be-released drug. Now that it’s scaled federal barricades, GW Pharmaceuticals hopes to have the medication available to patients around the country sometime in the next two months.
To compete with other epilepsy medications, Epidiolex is expected to cost more than $32,000 per year, a price significantly higher than what CBD medications cost in state-legal medical and recreational markets. Since the drug is now an accepted medication in the eyes of the federal government, though, insurance coverage could reduce those costs by tens of thousands of dollars.
The FDA and DEA have previously approved synthetic cannabinoids for medicinal use, but Epidiolex is the first product extracted directly from the cannabis plant to garner official acceptance from the federal narcotics agency.
“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,” GW’s CEO Justin Gover said in a press statement.
“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.”