State approves first drug containing CBD

State approves first drug containing CBD

In a teleconference on Tuesday, Wisconsin’s Controlled Substances Board passed an order to schedule the drug Epidiolex and any similar drugs containing cannabidiol approved by the U.S. Food and Drug Administration as a schedule V controlled substance.

Epidiolex is a medication containing CBD, a component of cannabis, approved to treat seizures.

It was the first drug with CBD approved by the FDA.

In order for it to be used in the U.S., the Drug Enforcement Administration had to reschedule it. Marijuana is a schedule I drug, making Epidiolex schedule I, too. So in late September, about three months after the FDA’s approval, the DEA changed Epidiolex and any other FDA-approved drugs containing CBD to a schedule V drug.

Wisconsin has now also changed approved drugs with CBD and no more than 0.1 percent THC to a schedule V drug. Right now Epidiolex is the only drug in that category.

Patients with uncontrollable epilepsy should be able to have access to the drug soon, since the order goes into effect Oct. 15.

Wisconsin patients with epilepsy like Adalyn Hiles will now be able to use the drug Epidiolex. It is the first @US_FDA-approved drug that contains #CBD. The state Controlled Substances Board just changed #Epidiolex to a schedule 5 drug, effective Oct. 15. #news3

— Amanda Quintana (@AmandaQTV) October 9, 2018

Doctors are already planning to use the drug to treat the seizures of 6-year-old Adalyn Hiles, of Janesville.

“Nothing in medicine is the holy grail. There are always benefits and side effects, and we’re going to take that same attitude toward this drug,” said her neurologist, Dr. Frederick Edelman.

Adalyn’s family has voiced its frustration with the legal hurdles Epidiolex faced. Her parents said they were running out of options to treat their daughter, and they believed Epidiolex could be the answer.

“It’s like you have cancer and someone has a cure. And they’re like, ‘Hey, I’ve got this cure.’ Alright, great, can I have it? ‘Nah, I’m going to keep it; I’m going to hold on to it. Let’s wait awhile,'” said Jason Hiles, Adalyn’s father.

As they awaited the approval of Epidiolex, Adalyn’s parents began treating her with CBD oil, a product labeled as a supplement from a local wellness store.

They say it has brought her seizures down from 5 to 6 seizure events per night, each lasting 10 minutes to an hour, to being almost seizure free. But the CBD oil is not regulated.

“It’s pretty silly. I’m treating my daughter out of a health food store instead of being able to go through the right channels. Her doctor can’t even talk about the cannabis oil and give us dosing guidelines or directions or anything of that nature,” said Hiles.

Now that Epidiolex has been approved for use in Wisconsin, Hiles says this is a start.

“Epidiolex – it shouldn’t stop here. It’s one source, it’s one tool, it’s one resource. But we’ve got to continue this process to really look at specifically cannabis oil and see how it can be medically cleared and overseen by the professionals, and definitely monitored, but be available and be a viable option to take care of my daughter as well as people with like conditions,” said Hiles.

Tuesday’s action by the Controlled Substances Board does not affect the regulation of CBD products and supplements. It only allows the prescription use of Epidiolox.

Even after advocating for Epidiolex, Hiles is not sure Adalyn will immediately start using the drug because the CBD oil she is currently using is working so well.

“We’re having such good control that you don’t want to mess up what you have, because you may not ever get it back,” said Hiles.