America’s problem with marijuana is that it gets you high. That’s changing now, as legalization spreads and attitudes change, but perhaps the most important shift that’s occurred is that we now better understand which parts of the plant are psychoactive and which aren’t. Cannabidiol (CBD) is a marijuana compound that doesn’t get you high — but, as researchers showed Wednesday in The New England Journal of Medicine, it has powerful effects elsewhere in the brain.
In the study, the researchers from New York University School of Medicine show that administering a dose of CBD to people with a severe form of epilepsy can significantly reduce the number of seizures they experience. Lennox-Gastaut syndrome usually begins in childhood, manifesting in clusters of extreme seizures that cause people to suddenly drop or stiffen. People with the illness are often unresponsive to existing anti-epileptic medications. “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,” said study leader Dr. Orrin Devinsky, director of NYU Langone’s Comprehensive Epilepsy Center, in a statement published Wednesday.
Devinsky’s team used an existing cannabidiol-based drug called Epidiolex, an oral solution, in their study on 225 international patients with Lennox-Gastaut syndrome. They were divided into three groups that either received a high dose, a medium dose, or a placebo dose of CBD twice a day for 14 weeks. Tracking the frequency of their seizures during the study period and for four weeks before and after the experiment began, the researchers found that the people who received a high dose (20 milligrams per kilogram body weight per day) had a 41.9 percent reduction in “drop seizures.” Those who got the medium dose of 10 milligrams saw a reduction of 37.2 percent, and the placebo group had a 17.2 percent reduction.
Epidiolex wasn’t perfect, though — this was a Phase 3 trial — as it had some side effects, which included sleepiness, decreased appetite, diarrhea, upper respiratory infection, fever, vomiting, cold-like symptoms, and, in extreme cases, strings of epileptic seizures that followed one after another. There are some concerns that it can also increase the levels of harmful liver enzymes, but the researchers say that this can be managed as physicians track their patients as they take the drug.
On April 20, the US Food and Drug Administration voted to recommend approval of a new drug application for Epidiolex after a meeting where Devinsky and his team presented the findings in this paper. The FDA is expected to give its final verdict on the drug in late June.
Whatever the FDA decides, the success of this cannabidiol-based drug is a landmark achievement for researchers in the medical marijuana field, whose greatest challenge likely won’t be finding applications for the plant’s compounds but rather convincing the public that not all of them get people high.