Epidiolex, a plant-derived cannabidiol (CBD) with no mind-altering effects, has been approved by Japanese Ministry of Health, Labor and Welfare for clinical trials in epileptic patients with Dravet and Lennox-Gastaut Syndromes. Japan does prohibit cannabis-based agents although there are some exemptions for hospitals via its Cannabis Control Act. According to Hemp Today, 3,000 residents have Dravet in Japan; 4,300 struggles with Lennox-Gastaut.
The U.S. Food and Drug Administration approved the use of Epidiolex. It is the first cannabis-derived prescription therapy securing federal approval in the U.S. for patients age 2 and older with two severe forms of epilepsy (Dravet and Lennox-Gastaut).
The therapy was developed by GW Pharmaceuticals and lists for $32,500 annually according to in-Pharma Technologist.
Dravet Syndrome News reports that the EU via European Medicines Agency is reviewing Epidiolex for treating Dravet and Lennox-Gastaut as well.
Results from two Phase 3 clinical trials include the following:
Antiepileptic Efficacy Study of GWP42003-P in Children and Young Adults with Dravet Syndrome (GWPCARE1)
GWPCARE5 An Open-Label Extension Study of Cannabidiol (GWP42003-P) in Children and Young Adults with Dravet or Lennox-Gastaut Syndromes