Adding to the weight of recent research, a new study in The New England Journal of Medicine has documented more evidence of the impact of cannabidiol (CBD) in treating seizures. The study specifically tested the CBD-based drug Epidiolex, which is manufactured by the British company GW Pharmaceuticals.
The findings come on the heels of an FDA panel’s recommendation to approve Epidiolex for the treatment of two rare forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, two of the most difficult types of epilepsy to treat. Nearly all patients with Lennox-Gastaut or Dravet continue to experience seizures on all the currently available medications. Both syndromes manifest in children, with Lennox-Gastaut appearing between ages 3 and 5, and Dravet starting even earlier.
The FDA panel, comprised of outside scientists, reviewed the current scientific literature and heard testimony from patients, ultimately voting 13-0 in favor of recommending approval. While the panel’s unanimous review of the drug makes final approval by the FDA more likely, an official decision is not expected until late June, according to Justin Gover, CEO of GW Pharmaceuticals.
A previous study, published in The New England Journal of Medicine a year ago, found that CBD reduced the number of seizures in patients who suffered from Dravet syndrome. This latest research, which was headed by the same team out of the New York University (NYU) School of Medicine Langone’s Comprehensive Epilepsy Center, measured the impact of CBD on patients with Lennox-Gastaut syndrome.
“This new study adds rigorous evidence of cannabidiol’s effectiveness in reducing seizure burden in a severe form of epilepsy and, importantly, is the first study of its kind to offer more information on proper dosing,” co-lead author Orrin Devinsky said in a news release issued by NYU Langone Health, the school where he works. “These are real medications with real side effects.”
While the study was funded by GW Pharmaceuticals, it followed a phase 3 multi-center, randomized, double-blind, placebo-controlled protocol—in effect, removing the possibility of bias. The study, the first large-scale trial testing the effects of specific CBD medication doses, is being hailed as a landmark, and increases the chances of FDA approval.
Researchers wanted to assess the safety and efficacy of two different CBD doses measured against a placebo. Patients who did not receive the placebo added a high daily dose of CBD to their existing anti-epileptic medication regimen. Of the two groups of patients receiving CBD, one group took 20mg of CBD per kilogram of body weight, while the other took just 10mg per kilogram of body weight.
The results were overwhelmingly positive. The first group taking the higher dose experienced a median 41.9 percent decrease in seizures after 28 days. The second group experienced a reduction of 37.2 percent. Both of the active-drug groups far outpaced the control group, which only registered a 17.2 percent drop in seizures.
“This landmark study provides data and evidence that Epidiolex can be an effective and safe treatment for seizures seen in patients with Lennox Gastaut Syndrome, a very difficult to control epilepsy syndrome,” said co-author Anup Patel, MD, chief of Neurology at Nationwide Children’s Hospital, according to the release.
As positive as things are looking for the future of CBD, nothing is far from guaranteed. At least one other study is currently underway to measure the long-term benefits and risks of CBD treatment, but the FDA may find that still more research is needed before they grant final approval.