GW Pharmaceuticals won historic FDA approval back in June when the agency green-lighted its cannabidiol drug Epidiolex to treat rare and severe forms of epilepsy. But the new medication has been stuck in the starting gate, waiting for the Drug Enforcement Administration to decide how to handle the first-of-its kind drug.
Now, the DEA has made its move. GW reported Epidiolex will move from Schedule I to Schedule V, the DEA’s lowest—and most favorable for the drug’s rollout. Authorities can now finalize its label and the company can request a Schedule V license to sell it.
The upshot? Epidiolex should be available in about six weeks, the company says.
Medicines in the Schedule V class have proven uses and low potential for abuse, GW said. The DEA’s decision only applies to FDA-approved CBD drugs; unapproved CBD products remain in Schedule I, and the FDA has itself emphasized that Epidiolex is the only one it has given the go-ahead.
In a statement Thursday, GW CEO Justin Glover said his company is “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.”
The June U.S. approval for Epidiolex followed an FDA advisory panel’s unanimous vote in favor. Before the panel meeting, FDA staff also backed the drug, saying the company offered “substantial evidence” of efficacy.
In three clinical trials covering 516 patients with Lennox-Gastaut syndrome and Dravet syndrome, Epidiolex plus other antiepileptic medications reduced the frequency of seizures. The drug is approved in patients aged 2 and older.
The DEA rescheduling represents not only a boost for GW, but also other companies working toward FDA approval for their own CBD medicines, including AXIM Biotechnologies and Cure Pharmaceutical. In a statement at the time of the Epidiolex approval, AXIM CEO George Anastossov said the FDA nod was “highly encouraging for other pharmaceutical companies who are developing other naturally extracted, cannabinoid-based drugs for many other conditions.”
By: Eric Sagonowsky
Source: Fierce Pharma
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