New research into cannabidiol (CBD) has highlighted the considerable health benefits that even occasional doses of the cannabis compound can offer to people who suffer from a severe form of epilepsy.
Currently, only 6 medications are approved to treat seizures in patients with the syndrome, however, disabling seizures occur in most patients despite treatment. Side effects were reported in 94 of the patients in the 20 mg CBD group, 84 percent in the 10 mg group, and 72 percent of those taking the placebo.
In the current study, the researchers enrolled 225 patients (ages 2 to 55) with Lennox-Gastaut syndrome across 30 global sites in a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of two doses of CBD.
In this study, researchers used Epidiolex, a CBD medication manufactured by GW Pharmaceuticals, which became the first cannabis-based drug to be recommended by the United States' Food and Drug Administration (FDA) last month. All medications were divided into two doses per day for 14 weeks.
Lennox-Gastaut Syndrome is a rare and severe form of childhood-onset epilepsy that typically persists into adulthood.
During the 28-day baseline observation period, the combined average of drop seizures for all groups combined was 85. However, side effects were generally reported as mild or moderate in severity, and those that occurred in more than 10% of patients included: sleepiness, decreased appetite, diarrhea, upper respiratory infection, fever, vomiting, nasopharyngitis, and status epilepticus. Additionally, 14 patients who received Epidiolex had elevated liver aminotransferase concentrations.
"Our data from this study provides important insights about the dosage the can provide the best balance between effective seizure control and minimal side effects", Devinsky said. New study results from the clinical trial of Epidiolex® has shown to significantly reduce the number of seizures in patients with Lennox-Gastaut Syndrome.
Announcing positive results, GW CEO Justin Gover hailed the study's publication as another landmark moment for the company and touted its results as further proof of the cannabidiol's potential in the treatment of LGS. After treatment, the group treated with 20mg of Epidiolex experienced a 41.9% reduction in seizures, while the group that received a 10mg does experience a 37.2% reduction.
"We are now in the latter stages of the FDA's review of our New Drug Application and look forward to a decision from FDA in late June".