It’s been some time since we started seeing news about a CBD (cannabidiol) based medicine called Epidiolex being developed by the British company GW Pharmaceuticals. The marijuana-derived cannabinoid has proven useful in the treatment of seizures – and GW Pharmaceuticals has been conducting a drug trial using Epidiolex to treat two rare forms of intractable epilepsy, Dravet syndrome and Lennox-Gastaut syndrome (LGS), and the results of those trials are currently under review by the U.S. Food and Drug Administration (FDA).
If Epidiolex is approved by the FDA, then it will be one of the first cannabinoid-based medications – and the first derived from the cannabis plant itself, rather than synthetic versions of those cannabinoids – to be approved for doctors to prescribe to their patients. While it would be specifically approved for Dravet syndrome and LGS, there would be potential for physicians to prescribe the medication for other conditions as well.
“Although the review is still ongoing, the risk-benefit profile established by the data in the application appears to support approval of cannabidiol for the treatment of seizures associated with LGS [Lennox-Gastaut syndrome] and DS [Dravet syndrome,]” the agency said in a report.
On Tuesday, the new medicine received the above positive review from FDA clinicians, but the agency is not obligated to follow their recommendation, or even that of the advisory committee, which will discuss the approval of Epidiolex this week. Even if they are not bound to the determination of these reviews, the better things look early on, the better chance it has of being approved for use – likely becoming an alternative that will save countless lives and improve just as many more.
“Epidiolex, if approved, will mark a sea change in the acceptability of cannabinoids as therapy,” GW Pharma CEO Justin Gover told Bloomberg.
A decision could come from the FDA as soon as June 27th – and its approval could change the playing field when it comes to using cannabis-based medicines and certainly the legality of the classification of cannabis in the Controlled Substances Act (CSA), which lists the plant as though it has no medicinal value. This claim – and that of lack of research (at least when it comes to use in epileptic patients) – will no longer be valid, but will that force the DEA’s hand and, in turn, a rescheduling or removal of the plant from the CSA after all these years?