Dr. Paul Lyons, an epileptologist at Winchester Neurological Consultants, said the 20 patients with LGS epilepsy who enrolled in open label trials, as well as a double blind clinical trial for Epidiolex had life-changing results.
“Parents have told me that they have seen their children walk more effectively, laugh for the first time, reach for objects, track, have more meaningful relationships with their family members and caregivers.”
Epidiolex is made from CBD oil, which comes from marijuana leaves but doesn’t have any recreational use.
“The medications we used are derived from cannabis are not psychoactive, meaning they don’t make you high, they don’t cause euphoria, and in that way this is not a substance of a abuse, but rather a medication that can help treat a very serious disease,” Dr, Lyons said.
The medical trials were the only way parents like Tonya Viands could get effective treatment for her son Jayden’s, severe epilepsy.
In March, she said Jayden could walk again because of the medication, after spending most of his time confined to a wheel chair and experiencing violent seizures.
After Senate Bill 701 took effect on Friday, pharmaceutical processors were authorized to “ manufacture and provide cannabidiol oil and THC-A oil to be used for the treatment of intractable epilepsy,” according to Virginia’s legislative information system.
Dr. Lyons said G.W. Pharmaceuticals has agreed to supply each of the participants in his studies with a free supply of Epidiolex for the next three years, but everyone else has to find another way of getting the drug until insurance covers it.
According to Dr. Lyons, medicine like Epidiolex won’t be covered by insurance until it is approved by the FDA. After that, the DEA would have 90 days to reschedule CBD oil to a less restrictive schedule (ex. Schedule I to Schedule II).
Insurance coverage of prescription medications are determined after the medication is approved by the FDA.
Until then, Lyons and his colleagues are facing a challenge in making the drug accessible.
“So one of the challenges we’re facing with the work we’re doing with the Board of Pharmacy, and then from that, the state, is creating mechanisms with the new companies that will be created to ensure that all Virginians who need the drug, independent of their ability to pay for it, will be able to have access to it,” Lyons said.
Expanding access to CBD oils will be especially important if Virginia’s new law can encompass more than just Epilepsy treatment.
“There’s hope for other applications including chronic mental illness, gastro intestinal disease, and chronic pain syndromes,” Lyons said.
And with an addiction epidemic that many believe was spurred by over prescribing painkillers, Lyons says there could be some benefit to look into more uses for medical cannabis.
“There’s as many as 600 different chemicals or molecules in cannabis the plant, so the hope is that we’ll be able to replace some of the traditional pain killers, particularly the opioids that you referred to that’s unfortunately associated with addiction and substance abuse, with other medication that wouldn’t have the same effect.”
Lyons said extended trials for Epidiolex are underway.