Breaking the rules is GW Pharmaceuticals Plc (NASDAQ:GWPH), whose experimental medication Epidiolex, which may become the first cannabis-derived medication to win U.S. approval, found a backer in the Food and Drug Administration (FDA) on Tuesday. An agency staff report regarding the British pharmaceutical company’s experimental drug noted it had “substantial evidence” of effectiveness for hard-to-treat seizures in children. If approved, Epidiolex would be the first non-synthetic marijuana-derivative approved for medical use in the United States.
The drug is bred to have a high cannabidiol (CBD) content, according to company CEO Justin Gover. GW has purified the extract and given it a strawberry flavor to make it more palatable for children. Unlike tetrahydrocannabinol, or THC, which gives marijuana its euphoric effect, CBD does cause a psychotropic high but is still considered by many, at least anecdotally, to aid with a number of ailments.
“Epidiolex, if approved, will mark a sea change in the acceptability of cannabinoids as therapy,” Gover said, according to Bloomberg. GW Pharmaceuticals was up $11.17 per share, or 9.26 percent in early trading this morning, trading at $131.62 per share.
"I think it needs to be approved because everyone is using it across the internet without knowing the safety ... and no one is watching the interactions with other drugs," said Dr. Joan Conry of Children's National Health System in Washington, in an interview with the associated press.
Currently, the controversy over the legality of CBD has landed in front of the U.S. Court of Appeals for the 9th Circuit, where the Hemp Industries of America is challenging the Drug Enforcement Agency’s recent ruling that the extract be classified as a Schedule I Drug. Oral arguments in that case were heard this past February.
The possible approval of Epidiolex brings more questions than answers when it comes to the legality of CBD and CBD oil. As lawyer and cannabis activist Rod Kight told PotNetwork in an interview earlier this year, in the past, the FDA has not been so open to the idea of CBD.
“The big question is, what happens when the FDA approves Epidiolex as a drug? Is that the point the FDA will say okay, well, now CBD is a restricted drug,” Kight said earlier this year. “You can get it through Epidiolex if you're prescribed it, but you just can't use it to enrich other products or sell it over the counter for people to take, or will the FDA leave it alone? There's sort of some precedent for both views.”
Other activists have made the point that with the drug’s approval would nullify marijuana’s classification as a Schedule I drug, which by definition, means it has no medical value.
A decision on whether or not to approve Epidiolex is expected to come by June 27. According to Bloomberg, the FDA will discuss the drug with advisors this Thursday.