FDA approves first drug with marijuana component

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EXETER — The U.S. Food and Drug Administration on June 25 approved the first marijuana-based medication to be used for the treatment of patients with two severe forms of epilepsy.

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The FDA approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, in patients age 2 and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.

CBD is a chemical component of the cannabis sativa plant, more commonly known as marijuana. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC). It is THC, and not CBD, that is the primary psychoactive component of marijuana.

Dr. Richard Morse, a pediatric neurologist at Dartmouth-Hitchcock Medical Center, was part of one of the studies funded by Greenwich Biosciences, the UK-based pharmaceutical firm that created Epidiolex, and will have exclusive rights to it initially. He said the firm funded studies all over the world.

“We did our study on childhood epilepsy, looking at the efficacy of cannabidiol when used to treat the more severe forms of epilepsy,” Morse said. “We treated about 15 to 20 children here, with good responses.”

Epidiolex is different from medical marijuana in that CBD is isolated out and the THC component is not in the new drug.

“I think it is unique, the isolation of CBD,” Morse said. “People are using and believe in medical marijuana for a number of uses, multiple sclerosis, pain, spasms and other uses. It’s never been studied to see if maybe these patients only need the CBD component, but I suspect we will start looking at that now. There has definitely been a wildfire of interest.”

Part of the reason there has not been a lot of research is that the government has greatly restricted research. Morse said that might loosen a bit now.

Dr. Matthew Robertson, a neurologist at Portsmouth Regional Hospital, said the FDA approval could be the start of a new era and he is interested to see where this goes.

“I work primarily with adults,” Robertson said. “This drug has been approved for two specific types of childhood epilepsy. Of course, we use drugs off-label all the time, but the biggest block is insurance coverage. Getting an off-labeled use covered is always a challenge.”

Robertson said the FDA approval might be a way of getting a foot in the door, and other uses for Epidiolex and similar drugs might be explored in the future.

“I am hopeful it might be indicated for certain adult epilepsy cases,” Robertson said. “I can use off-label but not as often as I might like to.”

Dr. Geoffrey Starr of Core Neurology in Exeter said he knows some doctors and patients are interested in the news.

“People are looking for more natural remedies,” Starr said. “We know we have patients who are using medical marijuana. There are people who believe in the benefits, so having trials and studies are a very good thing.”

Starr said it is an arduous process to get a drug approved by the FDA.

“It takes millions of dollars and a lot of time to go through the process,” he said. “I think it is good there was a company who did the work and gave us what many of us already knew. People are using this. You can buy CBD oil on the internet. It is costly but available.”

The FDA has a bar set to determine if new medications should be approved. Morse said it must meet a 50 percent bar. In the case of epilepsy, that means patients must have a 50 percent or greater reduction is their incidence of seizures.

“Epidiolex met and slightly exceeded that bar,” Morse said. “Right now, there is confusion because only one company can offer this. I do think it will open the door to a lot more research for various ailments.”

Starr said doctors now use things like vitamin B2 and enzyme Q10 to help patients with migraines, even though they are not under FDA designations. He said it works for some patients, so if Epidiolex can help people, he is all for it.

“If I had a patient with epilepsy on a different medication and he tried this, and it worked better, I would definitely use it,” Starr said. “If it made that patient’s seizures disappear, why wouldn’t I use it?”

Robertson said he feels the concept of CBD has been well proven in epilepsy uses as something that works.

“There is a social stigma that leaves it as a last-ditch effort for use,” he said. “I hope in the future that is resolved so we could use it as the first line of defense rather than the fourth, if it is indicated as the best choice.”

Robertson certifies patients for medical marijuana, legal in New Hampshire, but still not recognized federally.

“It’s like going behind the curtain to dispense,” he said. “I don’t know the strain; the dispenser and they don’t know my patient. I don’t really have specific dosage information and rely on asking my patients how it’s working for them.”

One thing that speaks to Epidiolex over medical marijuana is consistency. Morse said the drug will always be required to meet the same standards, where medical marijuana can vary by supplier.

Robertson said he doesn’t want to see the product over-controlled, but would like better information on options for knowing what he is prescribing.

Starr added that because the drug contains no THC, it will have less abuse potential.

“I would advise my patients to see this as a medication,” Robertson said. “There are possible side effects. It may be considered natural and so are many herbal medications, but all of them have the potential for interactions with other medications.”

Morse said he believes Dartmouth-Hitchcock will stock the drug once it is available, which is expected to be in September.

“Currently, it is classified as a schedule I drug which restricts its use, designating it as having no medical value,” Morse said. “The FDA must reclassify it before it can be used. I think they will make it a Schedule III, the category that most drugs needing a prescription are classed as.”

Starr said he doesn’t know if the Exeter Hospital pharmacy will be as quick to stock Epidiolex because he said it does not have a practice dedicated to childhood epilepsy. He said it’s more likely specialist practices in the area will stock the new drug.

Morse said once reclassified he believes Epidiolex will be covered by insurance for its designated use. He said it will probably be explored for off-label uses and that might not be covered.

“There are lots of people who do not respond well to traditional medication used to treat epilepsy,” Morse said. “This is another tool and it may help people who are refractory to medications we now use. It is not a cure but is seems to work well and is safe.”

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