While marijuana has proved to be an effective green herb in treating epilepsy since ancient times, a large-scale study dubbed as the “first” of its kind offers new details on the “proper dosing” needed to remedy severe forms of epilepsy called Lennox-Gastaut syndrome.
What the researchers found is a 41.9 percent reduction in “drop seizures” – a type of seizure that results in severe loss of muscle control and balance – when patients took a 20 mg/kg/d CBD regimen, a 37.2 percent reduction in those on a 10 mg/kg/d CBD regimen, and a 17.2 percent reduction in a group given a placebo.
The research was published online Thursday in The New England Journal of Medicine.
Its phase III was led by principal investigator and study first co-author Orrin Devinsky, MD, a professor of neurology, neurosurgery, and psychiatry at NYU School of Medicine and director of NYU Langone’s Comprehensive Epilepsy Center.
“It is the first study of its kind to offer more information on proper dosing,” Dr. Devinsky said.
“This new study adds rigorous evidence of cannabidiol’s effectiveness in reducing seizure burden in a severe form of epilepsy.”
“These are real medications with real side effects, and as providers we need to know all we can about a potential treatment in order to provide safe and effective care to our patients.”
Epidiolex is manufactured by the British GW Pharmaceuticals. However, GW Pharmaceuticals operates in the U.S. as Greenwich Biosciences.
GW Pharmaceuticals also funded the clinical trial, which included 225 patients – aged 2 to 55, who suffer from Lennox-Gastaut syndrome across 30 international sites in a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of two doses of CBD.
Seventy-six patients received 20 mg/kg/d CBD, 73 received 10 mg/kg/d CBD, and 76 were given a placebo.
All medications were also divided into two doses per day for 14 weeks.
To compare before and after, the number of seizures were monitored four weeks prior to the start of the study. The seizures were later tracked throughout the 14-week study period and afterward for a four-week safety check.
The federal agency’s recommended Epidiolex after a meeting with researchers among them was Dr. Devinsky.
The agency, meanwhile, will decide whether to approve the medication in late June.
Dr. Devinsky said more research needs to be done despite the good news.
“More research remains imperative to better determine the effects of CBD and other similar cannabis-derived compounds on other forms of the disease and in more dosing regimens.”