While discussions swirl around the largely untested benefits
of medical marijuana and state-by-state policies, one medication derived from
the marijuana plant is on its own trajectory. Now in a third published study of
patients with rare seizure disorders, Epidiolex, a pure cannabidiol (CBD) oral solution with no THC, has been found to significantly reduce the frequency of drop
seizures, a type of seizure that causes sudden loss of muscle strength.
Published in this weeks New England Journal of Medicine,
the study comes less than a month after the drug unanimously passed a Food and
Drug Administration advisory panel.
The multi-center trial, which included the University of
Cincinnati (UC) Medical Center, looked at the effectiveness of two dose levels
of pure cannabidiol in reducing the frequency of drop seizures in patients who
have Lennox-Gastaut syndrome (LGS)a severe, yet rare form of epilepsy with an
incidence of approximately two cases per 100,000 population.
"This trial involving children and adults with LGS showed
that a pharmaceutical formulation of purified cannabidiol, resulted in a
significantly greater reduction in the frequency of drop seizures than in
placebo, says Michael Privitera, MD, professor of neurology, director of the
Epilepsy Center at the UC Gardner Neuroscience Institute and a co-author on the
In study participants, the average (median) seizure
frequency dropped by 41.9 percent in the group that received 20 mg of
cannabidiol and a 37.2 percent drop in seizure frequency in the group receiving
10 mg (compared to placebo results at just 17 percent).
A total of 225 patients (12 in Cincinnati) participated
across 30 centers in the randomized, double-blind, placebo controlled trial;
overall, 6 percent (13 patients) discontinued due to adverse events.
The most common adverse events cited among patients was
drowsiness/sleepiness, decreased appetite and diarrhea. Abnormal liver function
tests were seen in 9 percent of participants but were reversible in all
Privitera, who has been researching anti-seizure medication
for 30 years, says this is a historic study. "The field has been waiting for
rigorous, scientific evidence that cannabidiol is effective and safe for
epilepsy, he adds. "This study puts those doubts to rest.
If the FDA follows the advisory panels recommendation,
Epidiolex would be the first cannabis-derived prescription medicine available
in the U.S. There are drugs on the market made from synthetic versions of THC
or other compounds found in the plant.
The trial was funded by GW Pharmaceuticals, manufacturer of
Epidiolex. Privitera cites no conflicts of interest.
You can read more about how the trial has impacted one
family here: http://magazine.uc.edu/issues/0317/chasing-calm.html