On September 26, 2016, GW Pharmaceuticals, a British company, announced a second positive Phase 3 pivotal trial for Epidiolex (cannabidiol) in the treatment of Lennon-Gastaut Syndrome, a rare and severe form of childhood-onset epilepsy.
According to GW’s website:
“In this trial, Epidiolex, when added to the patient’s current treatment, achieved the primary endpoint for both dose levels with high statistical significance. During the treatment period, patients taking Epidiolex 20mg/kg/day achieved a median reduction in monthly drop seizures of 42 percent compared with a reduction of 17 percent in patients taking placebo (p=0.0047), and patients taking Epidiolex 10mg/kg/day achieved a median reduction in monthly drop seizures of 37 percent compared with a reduction of 17 percent in patients taking placebo (p=0.0016).” (Ref: Read More)
These results from the Phase Three clinical trial appear impressive and, assuming there are no undiscovered or undisclosed glitches, Epidiolex should be on the way to FDA approval soon. CBD may present a unique situation for the FDA in that, unlike dronabinol, the synthetic THC medicine, CBD is reported to have no abuse potential and, therefore, the FDA may recommend that it NOT be scheduled under the Controlled Substances Act. Under the law, if FDA recommends against scheduling, the DEA cannot schedule the drug. The fact that CBD is a molecule found in the marihuana plant made it a de facto Schedule I controlled substance but the CSA allows for such designations to be changed, including for a scheduled drug to be withdrawn completely from the schedules if and when a FDA medical and scientific assessment warrants such change.
If FDA approves GW’s NDA for CBD, then it will be covered by the federal Food, Drug, and Cosmetic Act, which is enforced by FDA, which means that all products containing CBD and distributed as medicine must meet FDA standards. This should close down the Internet suppliers and the black market in CBD that thus far has thrived selling bogus CBD or CBD contaminated with THC and other impurities..