or could have led to a fall, injury, slumping in a chair or hitting
the patient’s head on a surface.” Patients often experience developmental and intellectual disabilities and require lifelong care.
During the trials for LGS—the results of which were published
in The Lancet— researchers randomized 171 participants and
administered either Epidiolex or a placebo in order to determine
the efficacy of the drug on drop seizures and other symptoms.
Trial participants ranged in age from 2 to 55 and were suffering from a median of 74 drop seizures per month. Ultimately,
patients taking Epidiolex saw a 50 percent reduction in the
number of monthly drop seizures compared to those taking the
placebo alone, and the overall number of seizures suffered was
reduced by 41 percent. Some patients did experience adverse
effects similar to those felt by Dravet syndrome patients; 12
patients discontinued their treatment because of these effects,
but they were resolved by the end of the 14-week study for 61
percent of those taking Epidioelx. One fatal case of acute respiratory distress syndrome was reported but was determined to be
unrelated to the medication. Overall, the trial found Epidiolex,
when used in conjunction with other applicable anticonvulsant
therapies, was effective in decreasing the number of drop and
other seizures compared to the placebo and was generally well
What makes Epidiolex different from going to a dispensary (in an
area where they are, of course, legal) and purchasing CBD oil? The
benefit, Schultz says, it the drug’s pharmaceutical-grade status—and
all that comes with it.
“You don’t know what you’re buying at the dispensary level, and
the results when these products are tested are disconcerting at best,”
Schultz said. “It’s widely known THC levels and CBD levels tend to
vary in most cases quite dramatically in these places. With an FDA
approval, you get the confidence that what you’re giving the patient
has instructions based on clinical experience and has a fully charac-
terized safety profile that guides the physician—something especially
in polytherapy environments.”
Schultz said he expects the DEA to change Epidiolex’s classifica-
tion from a Schedule 1 to one that’s less restrictive, such as a Schedule
4 or 5, given the finding the drug has very little abuse potential. That
official decision is forthcoming. In the meantime, GW Pharmaceu-
ticals and Greenwich Biosciences are looking to expand Epidiolex
into treatment of other conditions, as they will soon see results from
Phase 3 trials for Tuberous Sclerosis Complex and infantile seizures.
They’re also commencing trials within their pipeline of CBD-based
products to include those that treat autism spectrum disorders, Rhett
syndrome, schizophrenia and glioblastoma.
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