The developer of the experimental drug derived from marijuana announced that its first major clinical trial has been successful in reducing epileptic seizures.
This discovery can accredit the medical marijuana movement.
The drug is called Epidiolex and was developed by GW Pharmaceutical.
They stated that Epidiolex succeeded to achieve the most important goal of the trial, which was to lower the convulsive seizures in comparison with a placebo in Dravet syndrome (rare epilepsy form) patients.
Epidiolex is a liquid which contains cannabidiol, a marijuana component which doesn’t make people “high”.
However, if this drug gets regulatory approval, it’ll become the 1st U.S. prescription drug extracted from marijuana.
GW states that the existing drugs aren’t helpful enough for about 30% of almost 500,000 children with epilepsy in U.S. A lot parents of children with epilepsy want to try extracts from marijuana, of course made by medical marijuana dispensaries.
As a result of the pressure from these parents, many states considered or passed legislation to make marijuana-based products more easily obtained.
Some families even moved to Colorado, and become “marijuana refugees” since that’s the place where getting a particular extract called Charlotte’s Web is much easier.
The name Charlotte’s Web comes from the girl who first used it in the treatment of seizures.
There are hundreds of other young adults and children who are using this drug under certain programs which permit usage of experimental drugs to desperate parents, outside of clinical trials.
Although many parents stated they noticed significant seizure reductions, experts say that in order to ensure they do work, they have to be compared with a placebo.
Dr. Orrin Devinsky of the Comprehensive Epilepsy Center at New York University Langone Medical Center, the study’s lead investigator, stated that she is happy with this study, as they did things in the way they should be done.
She continues to say that systematic assessments of medical marijuana need to be done in America.
There were 120 children involved in the study, with an average of 13 convulsive seizures in a month and an average age of ten.
They were taking an average of 3 other epilepsy medicines. 60 children were randomly chosen to take placebo, and the other 60 the drug, as an addition to the epilepsy drugs they were already taking.
At the end of the 14-week treatment, the results of the two groups were statistically different.
It was proven that the children who took the drug Epidiolex had reduced frequency of convulsive seizures by 39%, whereas those taking the placebo by 13 %.
As a result of side effects, 1 child who took the placebo, and 8 children who took Epidiolex have withdrawn from the trial.
These side-effects included diarrhea, drowsiness, fatigue, vomiting, decreased appetite, upper respiratory infection, and fever. However, GW Pharmaceutical reported that overall, Epidiolex was well tolerated.
The company stated that the full details of the study will be presented at a medical conference.
GW, based in London, said that they plan a meeting with the Food and Drug Administration to see if this drug can be approved on the basis of this one study.
They added that results of another Dravet syndrome trial are expected later this year, as well as of two more Lennox-Gastaut(form of epilepsy) trials.
The company says that no specific drugs for Dravet syndrome have been approved. This form of epilepsy begins in infancy and affects approximately 5,000 kids in America.
Dr. Devinsky said that it’s still not known if Epidiolex can aid in the intellectual disability and walking problems that come with Dravet syndrome.
Sativex, used in the treatment of spasticity related to multiple sclerosis, is sold by the company which specializes in pharmaceuticals based on cannabis.
However, although this drug is approved in many countries, it is not in U.S.
Although Epidiolex has the chances of becoming the first prescription drug extracted from marijuana in U.S. there are 2 other drugs, nabilone and dronabinol, which are currently on the market and which are similar or identical to the marijuana component which produces the highs, delta-9 THC.
These drugs are approved in the cancer chemotherapy for the treatment of nausea and vomiting. Moreover, patients with AIDS can also use Dronabinol to treat appetite and weight loss.
As GW executives state, all of these other products based on marijuana haven’t undergone the same rigorous tests.
Last year, researchers at Johns Hopkins University and elsewhere conducted a study which discovered that medical marijuana products seldom consist the labeled amount of ingredients.
However, even if Epidiolex gets approved, there will be some parents who will continue with the products their children already use in order to prevent disruption of their treatment, or if they want a fuller plant extract to the Epidiolex’s single ingredient.
For instance, Allison Ray Benavides, a mother of 6 year old Robby says she doesn’t want to make any changes in his treatment as he is stable.
Robby uses Charlotte’s Web which includes little of THC, psychoactive component.
Medical social worker in San Diego, Ms. Ray Benavides, stated that while Robby was using the approved Depakote, he was experiencing 15-25 seizures on a daily basis, which was why he constantly wore a helmet, in order to protect his head from the constant falls.
He has had a total of 5 seizures since he had started taking Charlotte’s Web together with the Depakote.
Although she did welcomed the trial results of Epidiolex, she stated that she’s not interested in the double-blind placebo-controlled study.
According to analysts, Epidiolex is expected to be more expensive, $2,500-$5,000 a month, than some other medical marijuana products which cost from $100 to $1000 a month.
Nevertheless, unlike the other products, Epidiolex has chances to be covered by insurance.