GW Pharmaceuticals plc (NASDAQ: GWPH) confirmed Monday it has obtained a notice from the Drug Enforcement Administration certifying that its Epidiolex oral solution has been descheduled and is no longer a controlled substance.
“This notification from DEA fully establishes that EPIDIOLEX, the only CBD medicine approved by FDA, is no longer a controlled substance under the federal Controlled Substances Act,” GW Pharma CEO Justin Gover said in a statement.
Gover thanked the DEA for confirming "the non-controlled status" of the medicine.
"Importantly, the descheduling of EPIDIOLEX has the potential to further ease patient access to this important therapy for patients living with Lennox-Gastaut Syndrome and Dravet syndrome, two of the most debilitating forms of epilepsy," he said.
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After obtaining the DEA notice, the Cambridge, U.K.-based company said it has filed a post-approval supplement with the FDA to lift the Schedule V designation from the drug. GW Pharma said it is now working on enforcing these amendments at the state level and via the Epidiolex distribution network.
Once all the changes have been enacted, the drug can be prescribed just like any other non-controlled medicine, with a prescription being valid for one year.
This allows doctors to prescribe the drug more freely, without the demands of state prescription drug monitoring programs, according to GW.
GW Pharma shares were trading 4.66% higher at $90.62 at the time of publication Tuesday.
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Photo courtesy of GW Pharmaceuticals.
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