For the first time, the United States Drug Enforcement Administration has descheduled a cannabis-based pharmaceutical. The drug is called Epidiolex and is used to treat two of the most debilitating forms of epilepsy.
Epidiolex, a CBD-based medicine made by GW Pharmaceuticals plc (NASDAQ: GWPH), was removed from the country’s list of controlled substances in a move designed to ease patient access, the company said in a statement Monday.
Epidiolex, which contains less than 0.1 per cent THC and is therefore considered non-psychoactive, is the only weed-derived medication approved by the U.S. Food and Drug Administration. It is used for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome in patients two years of age and older.
The descheduling of Epidiolex means doctors can prescribe it free from the requirements of state prescription drug monitoring programs, those prescriptions will be valid for up to one year and will be transferable between pharmacies, GW Pharma said.
The medicine is marketed in the U.S. by Greenwich Biosciences, the American subsidiary of GW Pharma.
The company, founded in 1998, is a biopharmaceutical company focused on finding, developing and commercializing novel therapeutics derived from cannabis.
Epidiolex is their leading product. As well as being prescribed to treat LGS and Dravet syndrome, it also has an orphan drug designation from the FDA for the treatment of seizures associated with Tuberous Sclerosis Complex (TSC). The company submitted a supplemental drug application to the FDA in February so Epidiolex can be prescribed to treat TSC as well.
Epidiolex is approved as a therapy for LGS and Dravet syndrome in the United Kingdom and the European Union where it is marketed as Epidyolex.
Read more: UK approves 2 cannabis-based medicines
GW Pharma’s stock has been on a steady rise since the company’s Monday announcement, from US$85 per share to US$97.65 at close on Wednesday.
Top image via GW Pharma