Parents with children suffering from treatment-resistant epilepsy got a major reason for hope this week as the U.S. Food and Drug Administration cleared the way for a cannabis-based medication from a major pharmaceutical company to be made available by prescription across the country.
Epidiolex, a product of U.K.-based GW Pharmaceuticals, was first approved last June for the treatment of two specific, rare forms of childhood epilepsy: Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS). Epidiolex is also indicated for a condition known as Tuberous Sclerosis Complex, a genetic disease that causes the formation of tumors on different organs of the body.
Available in the form of a fruit-flavored syrup that is administered orally twice a day, Epidiolex is essentially purified, pharmaceutical-grade cannabidiol, or CBD. This is different from tetrahydrocannabinol (THC), the psychoactive ingredient in marijuana that brings on a “high” in the user.
CBD is essentially a relaxant as well as (according to anecdotal evidence) an effective pain reliever. Although it has been thoroughly studied (the clinical trials involved 500 subjects with treatment-resistant epilepsy), it is unclear why it reduces the seizures experienced by patients with DS and LGS. They only know that it works when other treatments fail.
In a statement to the British media, GW Pharmaceuticals CEO Justin Gover said, “Because these patients have historically not responded well to available seizure medications, there has been a dire need for new therapies that aim to reduce the frequency and impact of seizures.” He pointed out that Epidiolex “… has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and is eligible to be covered by insurance for appropriate patients.”
That clinical testing is a big selling point for GW Pharmaceuticals. CBC ointments and tinctures have long been available in states that have legalized marijuana, such as Colorado and Washington – and parents of epileptic children have already been using such products successfully. However, such CBD products are largely unregulated and have not been subject to clinical testing.
One parent who had considered relocating to a “pot-friendly” state for the sake of her epileptic daughter changed her mind when she learned about Epidiolex. “’I preferred this to some of those other options because it’s is a commercial product that has gone through rigorous testing,” she said.
Dr. Elaine Wirrell, who heads a program for pediatric epilepsy at the Mayo Clinic, agrees. She says, “I’m really happy we have a product that will be much cleaner and one that I know what it is.” When it comes to CBD products available over the counter from cannabis retailers, Wirrell notes, “There’s often a huge variation in doses from bottle to bottle depending on where you get it.”
On the other hand, purveyors and producers of commercial CBD products aren’t too concerned about Epidiolex cutting into their market share. Heather Jackson, CEO of the medical marijuana advocacy group Realm of Caring, says,” I really don’t think it’s going to affect us much. I don’t know a mom or dad in their right might who is going to change what’s already working.”
There is also the matter of cost. OTC CBD products are relatively inexpensive; families who use them typically spend an average of $150 per month. On the other hand, the cost for Epidiolex is expected be well over $2000 a month, though GW has not yet made an announcement about pricing. The good news for patients (at least those with coverage) is that because of FDA approval, insurers will be more likely to cover it.