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Rare Disease

Restrictions lowered for cannabis-derived drug

DEA reschedules Epidiolex, an FDA-approved cannabidiol treatment for rare seizure disorders

by Britt E. Erickson
October 7, 2018 | APPEARED IN VOLUME 96, ISSUE 40

 

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The U.S. Drug Enforcement Administration has opened the door for GW Pharmaceuticals to begin selling Epidiolex, a drug that contains purified cannabidiol (CBD) extracted from cannabis plants. The agency announced on Sept. 27 that it is reclassifying the drug from Schedule I, the most restrictive class of drugs regulated under the Controlled Substances Act, to Schedule V, the least restrictive group.

Epidiolex was approved by the Food & Drug Administration in June for treating seizures associated with two rare forms of epilepsy. It is the only CBD product so far to win FDA approval as a safe and effective drug.

“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,” GW CEO Justin Gover says in a statement.

DEA’s decision to reclassify Epidiolex does not change the status of non-FDA-approved CBD products that are already on the market. Those products, which include dietary supplements, cosmetics, and beverages, touting benefits like promoting relaxation and relieving anxiety and pain, will remain on Schedule I—drugs with no proven medical use and high potential for abuse.

As a result, any non-FDA-approved CBD products on the market could be seized by federal officials for violating federal law. Legal sources, however, say that such action is unlikely to occur unless a serious safety concern arises.

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