Drug regulators in the US have moved closer to giving their approval to the first-ever medication derived from a cannabis plant, following a resounding vote in support of a new CBD treatment for epilepsy.
In April, a panel of outside advisers to the FDA (Food and Drug Administration) unanimously voted that the drug’s benefits significantly outweigh its risks when treating two rare forms of childhood epilepsy known as Lennox-Gastaut syndrome and Dravet syndrome.
Obtaining the support of the advisory group is obviously crucial and with a landslide vote in favor of this CBD treatment option, there is every reason to be optimistic ahead of the official ruling which is due to be delivered by no later than June 27th.
Orrin Devinsky, an epilepsy specialist at the New York University Langone Medical Center and one of the leading researchers of CBD as a treatment for epilepsy, claimed: “It’s an enormous milestone. America clearly is moving, more so, and embracing cannabis as something that can be used medicinally.”
It is not uncommon for the FDA to source external experts to discuss drugs that are under review, especially when there may be some questions regarding the safety or effectiveness of that particular drug. While the FDA is not duty bound to follow the advice of the panel, either in this case or in others, the overwhelming nature of the vote would perhaps suggest that there is every chance that this particular CBD treatment will be approved in the coming month, setting a historic landmark in American medicine.
Convincing Clinical Studies
Following clinical trials of the drug, patients that added CBD to their existing treatment experienced an average reduction of between 40 and 50% in the most typical and onerous seizures that they endure.
This particular treatment has been shown to provide significant benefit for children with Lennox-Gastaut and Dravet syndromes in children aged 2 or over. Both are considered severe forms of epilepsy that begin very early in childhood and both are also highly resistant to many of the current existing medical treatments.
Shaun Hussain, an epilepsy specialist at the University of California, claimed “It’s pretty typical these children are having seizures every day. Some of them are having tens of seizures or hundreds of seizures each day.”
When you consider that as many as 20 percent of children with Dravet syndrome will die before reaching adulthood (according to the National Institutes of Health), it is fairly self-evident that current treatments are not proving to be nearly sufficient.
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Trial of CBD for Drug-Resistant Seizures in the Dravet Syndrome
Leading epilepsy specialist, Devinsky, who participated in the study a Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome, described the new therapy as a potential “life-changer” for sufferers of epilepsy.
In this particular study, the researchers enlisted children with Dravet syndrome, a very rare and often deadly form of epilepsy caused by a genetic mutation. These children suffer from multiple, prolonged seizures that can cause brain damage.
Until this point, there has been no specific treatment for Dravet syndrome and Devinsky, who is also director of the New York University Comprehensive Epilepsy Center, told NBC News “It's hard to portray how serious and devastating this is,”
In their analysis, Devinsky and other leading specialists from across the US used CBD on 120 Dravet syndrome patients. Half were given CBD for 14 weeks while the other half were given a placebo.
"Seizure frequency dropped in the cannabidiol-treated group by 39 percent from nearly 12 convulsive seizures per month before the study to about six; three patients’ seizures stopped entirely,” the team stated in the New England Journal of Medicine.