FDA approves first ever CBD based anti-epileptic drug
Did the FDA approve CBD for everyone? The short answer is no. The better answer is:
On June 25th the FDA announced that they had: “approved the first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy.”
The FDA went on to say: “The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome, and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with the Dravet syndrome.”
If you’ve Googled CBD it’s impossible to not come across Charlotte’s Web, the popular CBD brand. The Charlotte behind Charlotte’s Web is a famous story of a little girl with Dravet Syndrome, that went from suffering 300 seizures to zero seizures in one week after taking CBD.
Here’s a summary of Charlotte’s story:
By age five, Charlotte was suffering from up to 300 grand mal seizures a week — her body so ravaged by them that her heart even stopped several times. It got so bad that her doctors and parents eventually decided to put her in a medically induced coma to give her body a chance to rest and recuperate, even going so far as to sign a do-not-resuscitate order in case something went wrong.
Charlotte’s doctors told her parents that there was not much more that can be done for her… or was there?
Charlotte’s grandfather started reading about several success stories and testimonials from other parents that were using cannabis to help treat their children. There was one story that especially stood out — that of another boy with Dravet’s. The family decided that since their doctors made it clear that all clinical treatment options have been exhausted, what do they have to lose by trying cannabis? So, succeeding in getting hold of some R4 extract cannabis oil for Charlotte, they tried it and the results were almost immediate — going from seizing 300 times a week to NO seizures that entire first week after trying it out.
“I literally see Charlotte’s brain making connections that haven’t been made in years,” — Matt Figi.
After that first dose, Charlotte seized less and less frequently. Her parents, knowing that they were onto something, started looking for someone that could supply them with cannabis oil on a longer-term basis. Paige and Matt decided to contact the owners of a large medicinal marijuana dispensary to tell them their story in the hope that they will be able to help.
You can read Charlotte’s full story on medium.com.
Now that I know CBD can be used to treat Lennox-Gastaut syndrome, and Dravet syndrome, tell me more about the FDA approved Epidiolex.
Epidiolex’s effectiveness was studied in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome. Epidiolex, taken along with other medications, was shown to be effective in reducing the frequency of seizures when compared with placebo.
GWpharm the pharmaceutical company behind Epidiolex calls the medication: “the first pharmaceutical formulation of purified, plant-based CBD, a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs.”
GWpharm also stated: “In the Phase 3 studies, Epidiolex added to other antiepileptic therapies significantly reduced the frequency of seizures in patients with LGS and Dravet syndrome.”
“This study clearly establishes cannabidiol as an effective anti-seizure drug for this disorder and this age group,” said principal investigator and lead author of the study, Dr. Orrin Devinsky, director of the Comprehensive Epilepsy Center at New York University Langone Medical Center.
Elizabeth Thiele, MD, Ph.D., director of pediatric epilepsy at Massachusetts General Hospital, professor of Neurology at Harvard Medical School and a primary investigator for one of GW’s and Greenwich’s studies in LGS patients:
“As a physician who treats LGS and Dravet syndrome, I know that patients and their families usually face significant difficulties getting seizures under control using existing therapies, the results from these studies suggest that this pharmaceutical formulation of cannabidiol may provide hope for a new treatment option that may be effective for some patients.”
Are there any reported side effects of Epidiolex?
The most common side effects that occurred in Epidiolex-treated patients in the clinical trials were: sleepiness, sedation and lethargy; elevated liver enzymes; decreased appetite; diarrhea; rash; fatigue, malaise, and weakness; insomnia, sleep disorder and poor quality sleep; and infections.
What one thing should I take from this article?
In a June 2018 news release, the FDA announced its approval of a marijuana-derived drug called Epidiolex for the treatment of seizures in a subset of patients suffering from severe epilepsy.