By Cassandra Dowell
The Land of Lincoln’s medical marijuana program has been off to an extremely slow start—with not one patient yet receiving treatment from the pilot program that went into effect Jan. 1, 2014.
While eligible patients in the state await the production of medicine, those with seizure disorders are also keeping a close watch on Epidiolex, a liquid formulation of a pure plant-derived cannabidiol, also known as CBD. Epidiolex is being administered in numerous clinical trials throughout the United States, including Chicago. CBD has been shown to produce many of the medicinal benefits of cannabis while suppressing or balancing the psychoactive effects of THC.
Epidiolex is already showing promising results in treating severe forms of pediatric epilepsy, including Dravet syndrome and Lennox-Gastaut syndrome. The drug’s manufacturer, U.K.-based GW Pharmaceuticals (NASDAQ: GWPH), expects to submit the New Drug Application with the FDA around mid-2016, GW confirmed with MJINews. Approval would come after a review period once the application is submitted.
At the same time, dispensaries in Illinois may have products for patients before the end of this year. Getting access to products with high-CBD content has become a waiting game for Illinois’ seizure-stricken patients.
“We’ve been hearing from some growers in the state they’re targeting the beginning of October to have product available,” said Kurt W. Florian, Jr., president and CEO of the Epilepsy Foundation Greater Chicago. “And they’ve told us they will include products with high amounts of CBD—we’re looking forward to that.”
Epilepsy Foundation Greater Chicago has been a strong advocate for medical marijuana in the state, and is also keeping a close eye on pharmaceutical companies that are able to produce products with high amounts of CBD. “The big issue we see with medical marijuana is that doctors who are interacting with their patients don’t have experience with the cannabis products coming out of cultivation centers,” Florian said.
When it comes to medical marijuana from cultivation centers, there are many unknowns for doctors and patients alike. “They don’t have dosing information,” Florian explained. “Whereas, if the FDA approved a drug like Epidiolex, all that information, for example dosing and ratio of THC to CBD, makes it easier for the medical community. From a patient perspective, it would probably also make moms and dads more comfortable if the CBD was in a form similar to other pharmaceuticals versus going through trial and error to determine what is best for their children.”
In Illinois, one local media outlet is tracking the progress of a 5-year-old boy from the village of Morton who suffers from Dravet syndrome and is participating in an Epidiolex trial run out of Chicago. Dravet syndrome, also known as Severe Myoclonic Epilepsy of Infancy, is a “rare and catastrophic form of intractable epilepsy” that begins in infancy, according to the Dravet Syndrome Foundation.
In a recent study of 213 participants using Epidiolex, 137 patients who completed the study saw their number of seizures decrease by an average of 54 percent throughout the 12-week period. The study included participants between 2 and 42 years old (median age 11 years), and took place at 10 U.S. centers that were granted FDA-approved open-label Expanded Access, including NYU Langone Medical Center. NYU Langone led the research for the study.
Patients qualifying for the study had to have a treatment-resistant epileptic condition, such as Lennox-Gastaut or Dravet syndrome. Among 23 patients with Dravet syndrome who completed the study, convulsive seizures reduced by 53 percent, according to NYU Langone.
The study was an open-label trial, meaning both patients and researchers knew they were receiving the cannabidiol drug. Current research includes randomized, placebo-controlled trials.
GW will soon be opening an office in the United States in southern California to support its clinical trials and commercialization activities taking place nationwide, said Steve Schultz, vice president of investor relations at GW.
“There is confusion out there right now about the status of CBD products for epilepsy,” Schultz said. “One of the reasons physicians have approached GW is because they had some very serious concerns with these artisanal oils that are sometimes mixed in the kitchens of these parents in an effort to help their children. We believe the ultimate solution is not through a highly variable oil, but through a pharmaceutical medicine tested in placebo controlled trials.”
The trials, he said, will allow medical staff to know exactly what the drug does and does not do, and how it might react with other medicines—“all important data points for physicians prescribing and administering a new medicine to their patient.”
GW expects recruitment for the placebo controlled trials to wrap up this year, with initial data becoming available in late 2015. If the trials are successful, the company will then submit the data to the FDA for review.
For those with epilepsy and other medical conditions, getting access to CBD as soon as possible is top priority. “We are in favor of there being more research, but in the meantime we want to make sure we’re doing all we can to make all high content CBD products available,” Florian said.