GW Pharmaceuticals set to launch Epidiolex in US following scheduling by DEA

GW Pharmaceuticals on Thursday revealed that the US Drug Enforcement Administration rescheduled Epidiolex (cannabidiol) from Schedule I to Schedule V, permitting its launch in the country. GW Pharmaceuticals chief executive Justin Gover stated "with this final step in the regulatory process completed, we are working hard to make Epidiolex available within the next six weeks." 

Epidiolex was initially authorised by the FDA in June for the adjunctive treatment of seizures linked to Lennox-Gastaut syndrome or Dravet syndrome in patients ages two years and older, making it the first approval of a cannabinoid-derived prescription drug in the US. GW Pharmaceuticals later priced the therapy at $32 500 annually.

CEO Justin Gover remarked "we know there is excitement for a standardised version of cannabidiol that has undergone the rigor of controlled clinical trials and been approved by the FDA."  

Meanwhile, the therapy remains under review in Europe with a final decision regarding approval anticipated in the first quarter of 2019.  

For related analysis, see Physician Views Results: Neurologists positive on Epidiolex, but have analysts runaway with their forecasts? 

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