UPDATE: A representative from GW Pharmaceuticals clarified that Epidiolex is formulated to specifically treat Lennox Gastaut syndrome and Dravet syndrome. Scheduled date for pending approval by the FDA of Epidiolex is June 27. Lennox Gastault syndrome is a severe form of epilepsy, while Dravet syndrome is a severe form of epileptic encephalopathy; both conditions affect young children, typically diagnosed prior to four years of age.
DENVER–In an upside down case of regulatory disconnect, the first FDA-approved drug derived from cannabis may not be available to patients in Colorado, if approved by the Federal Drug Administration in June. In Colorado, pharmacies cannot sell cannabis medications, and cannabis dispensaries cannot sell FDA-approved drugs because they are not licensed pharmacies.
So, without a change in state regulatory law, the first FDA-approved drug derived from cannabis would be unable to be distributed for sale in Colorado.
Epidiolex, developed by Greenwich Bioscience (a subsidiary of GW Pharmaceuticals), is a non-psychotropic CBD oil formulation and an alternative treatment for patients with serious medical conditions, including epilepsy. Especially for young patients whose healthcare provider may be reluctant to recommend to a dispensary, Epidiolex could be prescribed through a conventional pharmacy–if Colorado lawmakers change current laws.
Representatives Lois Landgraf (R-Colorado Springs) and Janet Buckner (D-Aurora) have introduced a bill that would allow Colorado pharmacies to sell Epidiolex, while other non-FDA approved cannabis medicines would still be distributed through dispensaries. Currently, patients in Colorado, including children (through certified caretakers), access CBD oil and other medicinal products at cannabis dispensaries and patient facilities.
“Parents can still go to those dispensaries and get the product for their child. The other option [pending FDA approval] is that they [will be able to] get a prescription from their doctor that a pharmacist can legally fill and this would be a regulated product,” Landgraf told local Denver news affiliate CBS4.