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A drug derived from marijuana has triggered the first federal shift on cannabis in half a century, and experts predict an avalanche effect

A drug derived from marijuana has triggered the first federal shift on cannabis in half a century, and experts predict an avalanche effect

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  • The nation’s top drug regulator has officially changed how it regulates CBD, a marijuana compound in a new epilepsy drug called Epidiolex.
  • This is the first time the Drug Enforcement Administration has shifted its stance on cannabis in 46 years.
  • The DEA’s move comes nearly 90 days after Epidiolex was green-lit by another government regulator at the end of June.
  • Experts say the approval will galvanize research into other marijuana-based drugs.

A new marijuana-derived drug has led to a landmark change in the US government’s stance on cannabis.

After getting green-lit as the first federally-approved cannabis-based medication at the end of June, the drug has triggered the nation’s top drug enforcer to change how it regulates marijuana. It’s the first time the agency has shifted its stance on a marijuana compound in 46 years.

The drug is called Epidiolex and it is designed to treat two rare forms of childhood epilepsy using cannabidiol, or CBD, the compound in marijuana not responsible for a high. The latest move means that patients can now access the drug with a doctor’s prescription – although it won’t be cheap.

The Drug Enforcement Agency announced the change to its classification of FDA-approved drugs containing CBD on Thursday, nearly three months after the Food and Drug Administration approved Epidiolex as a medication.

Some researchers expected the agency to reschedule CBD entirely. Instead, the DEA rescheduled FDA-approved medications which contain the compound.

Still, experts say the approval could unleash a wave of new interest in the potential medical applications of CBD and other marijuana compounds.

‘We don’t have a choice on that’

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When the Food and Drug Administration approved Epidiolex in June, it triggered a countdown clock for action from the Drug Enforcement Agency to change its stance on marijuana.

“We don’t have a choice on that,” DEA public affairs officer Barbara Carreno told Business Insider just after the FDA approved Epidiolex. CBD, she said, “absolutely has to become Schedule 2, 3, 4, or 5.”

That’s not exactly what happened. Instead of rescheduling CBD, the agency chose to only reschedule drugs containing CBD which the FDA has already approved. At the moment, the only drug that fits the description is Epidiolex.

For comparison, popular ADHD medication Adderall is classified one step down from marijuana in Schedule 2. That means that while it can be legally prescribed by a doctor, it still is considered to have “a high potential for abuse” or harm. Schedule 5 drugs are those considered to have the lowest abuse potential and include drugs like cough syrups made with codeine.

Since 1972, the DEA has kept a tight lid on cannabis. That year, Nixon-era Attorney General John Mitchell named it a Schedule 1 drug “with no currently accepted medical use” – making all of its components, from psychoactive THC to non-psychoactive CBD, illegal.

But after the FDA green-lit Epidiolex, the Drug Enforcement Agency had 90 days to shift its position.

Carreno previously told Business Insider that the change would trigger what she called a “sea change” for CBD manufacturers and the industry as a whole, which up until now has existed in a kind of legal grey area with some manufacturers selling marijuana-derived CBD products only in states where marijuana had been legalized. It’s unclear whether that will happen now with the agency’s move.

Epidiolex vs. other CBD products

marijuana

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REUTERS/Michaela Rehle

Scientists and advocates representing families of patients with epilepsy have hailed Epidiolex’s arrival as a long-awaited treatment.

But they are also aware that desperate patients – especially parents of young children – may actively seek alternate sources of CBD that may be cheaper and don’t require a doctor’s prescription. In August, GW Pharmaceuticals, the company that makes Epidiolex, announced on a call with investors that the drug would cost roughly $32,500 per year.

In states where marijuana is legal (or in states with laws that had made CBD legal before the DEA rescheduled it), less expensive CBD-based oils and salves are widely available. But experts caution that these products may not be what they seem.

“What’s different with [Epidiolex] is that this is a well-studied and well-controlled product,” Lubbers said.

By contrast, most dispensary-grade CBD products are not well-studied or well-controlled.

For a 2017 study published in the Journal of the American Medical Association, researchers tested 84 products purchased from 31 different online CBD sellers. Roughly seven out of 10 items had different levels of CBD than what was written on the label. Of all of the items they tested, roughly half of the items had more CBD than was indicated; a quarter had less. And 18 of the samples tested positive for THC, despite it not being listed on the label.

“The main thing is that CBD as approved by the FDA is pharmaceutical-grade CBD. It’s manufactured under stringent standards, the same as other FDA-approved drugs,” Shlomo Shinnar, the president of the American Epilepsy Society and a professor of neurology and epidemiology at the Albert Einstein College of Medicine, told Business Insider in June.

A catalyst for more research into marijuana-derived drugs

Epidiolex’s approval could also be a powerful catalyst for deeper research into other marijuana-derived medicines. Cannabis has more than 400 compounds. CBD and THC are two of those compounds, and researchers think the others could hold promise as well.

Apart from CBD, researchers are also actively studying THC and other marijuana compounds for a range of potential medical uses, from relieving pain to soothing severe nausea. Although Epidiolex is the first marijuana plant-based drug to land FDA approval, the agency has already given the green light to drugs whose active ingredient is a lab-made version of THC, for example.

In the meantime, experts look forward to seeing Epidiolex made available to patients in need.

“I’m not currently aware of any other major new drugs that are close to being where this drug is,” Shinnar said.

The drug maker behind the first FDA-approved medication derived from marijuana has revealed how much it’ll cost

The drug maker behind the first FDA-approved medication derived from marijuana has revealed how much it’ll cost

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  • On a call with investors this week, GW Pharmaceuticals revealed the price of Epidiolex, its newly-approved, marijuana-based drug for rare forms of epilepsy.
  • Designed to treat two rare forms of childhood epilepsy using a marijuana compound called CBD, the drug is the first medication of its kind to get FDA approval.
  • The person leading the company’s commercialization efforts in the US said the goal is to keep the price of the drug on par with other epilepsy medications.

A marijuana-derived drug that recently became the first of its kind to win federal approval is not going to be cheap.

Called Epidiolex, the drug is designed to treat two rare forms of childhood epilepsy using a cannabis compound called cannabidiol (or CBD).

On a call with investors this week, British-based GW Pharmaceuticals, who makes the drug, said it would cost roughly $32,500 per year. The medication does not contain THC, the well-known psychoactive component of marijuana responsible for the drug’s characteristic high.

Julian Gangolli, who leads GW’s commercialization efforts in the US, said the price point would keep Epidiolex in line with other epilepsy drugs and was largely based on feedback from insurance companies.

Gangolli also said that he expected the wait time to receive the medication – after patients get a prescription from a clinician – to be three weeks, on average. But before any prescriptions for Epidiolex can be written, the Drug Enforcement Administration must reschedule its active ingredient, the marijuana compound CBD.

Currently, CBD is scheduled alongside marijuana as a schedule 1 drug with “no currently accepted medical use.” Beginning on June 25 when Epidiolex was approved, the agency had 90 days to reschedule or reclassify it as a schedule 2, 3, 4, or 5 substance.

“We don’t have a choice on that,” DEA public affairs officer Barbara Carreno told Business Insider in June. “It absolutely has to become Schedule 2, 3, 4, or 5.”

‘A breakthrough drug for an awful disease’

Epidiolex’s approval in June came on the heels of several months of promising research results and a positive preliminary vote from the Food and Drug Administration this spring. Experts are hopeful that the approval will unleash a wave of new interest in the potential medical applications of CBD and other marijuana compounds.

“This approval serves as a reminder,” Scott Gottlieb, the FDA commissioner, said in a statement shortly after the approval, “that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies.”

In three large clinical trials which the FDA considered before giving Epidiolex the official green light, researchers presented strong evidence that the pharmaceutical-grade CBD in the medicine had the power to significantly curb some of the worst symptoms of two of the hardest-to-treat forms of epilepsy, known as Lennox-Gastaut syndrome and Dravet syndrome.

“This is clearly a breakthrough drug for an awful disease,” John Mendelson, a panel member and senior scientist at the Friends Research Institute, said at a public FDA meeting this spring that was called to discuss the scientific merits of the drug.

But although the green light means that patients will soon be able to access Epidiolex with a doctor’s prescription, many will also likely turn to less expensive sources of CBD, such as those sold in marijuana dispensaries. Researchers and advocates caution against this, however, with the caveat that it’s impossible to verify that what’s in those products is actually pharmaceutical-grade CBD.

Gangolli added that with insurance, Epidiolex could be substantially cheaper than dispensary CBD.

“The cost of a co-pay [for Epidiolex] is significantly – or could be significantly – less onerous and burdensome than the cost of the product either over the internet or from dispensary,” Gangolli said.

A drug derived from marijuana has become the first to win federal approval, and experts predict an avalanche effect

A drug derived from marijuana has become the first to win federal approval, and experts predict an avalanche effect

source
Shutterstock

A new drug derived from marijuana just became the first of its kind to get the green light from the US government.

Called Epidiolex, the drug is designed to treat two rare forms of childhood epilepsy using a cannabis compound called cannabidiol (or CBD).

British-based GW Pharmaceuticals makes the drug. It does not contain THC, the well-known psychoactive component of marijuana responsible for the drug’s characteristic high.

The federal thumbs-up comes on the heels of several months of promising research results and a positive preliminary vote from the Food and Drug Administration this spring. Experts are hopeful that the approval will unleash a wave of new interest in the potential medical applications of CBD and other marijuana compounds.

“This approval serves as a reminder,” Scott Gottlieb, the FDA commissioner, said in a statement on Monday, “that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies.”

In three large clinical trials which the FDA considered before giving Epidiolex the official green light, researchers presented strong evidence that the pharmaceutical-grade CBD in the medicine had the power to significantly curb some of the worst symptoms of two of the hardest-to-treat forms of epilepsy, known as Lennox-Gastaut syndrome and Dravet syndrome.

“This is clearly a breakthrough drug for an awful disease,” John Mendelson, a panel member and senior scientist at the Friends Research Institute, said at a public FDA meeting this spring that was called to discuss the scientific merits of the drug.

But although the green light means that patients will soon be able to access Epidiolex with a doctor’s prescription, many will also likely turn to less expensive sources of CBD, such as those sold in marijuana dispensaries. Researchers and advocates cautioned against this, however, with the caveat that it’s impossible to verify that what’s in those products is actually pharmaceutical-grade CBD.

‘A boatload of evidence to show at this point’

Epidiolex 100mg Carton Bottle (unenhanced) (0074c) (j10)

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Courtesy GW Pharma

Starting last spring with a study presented at the American Academy of Neurology’s yearly meeting in Boston, GW Pharmaceuticals has consistently presented strong clinical studies that appear to support Epidiolex.

“There’s a boatload of evidence to show for this drug at this point,” Orrin Devinsky, a lead author on one of those studies and a neurologist at NYU Langone Health, told Business Insider.

A month after the Neurology meeting, Devinksy and his colleagues published a positive study of the drug in children with Dravet syndrome in the New England Journal of Medicine. Roughly 43% of the children in that study who got the drug saw their number of seizures cut in half, and 5% stopped having seizures entirely. In comparison, children who got a placebo had barely any noticeable change in their symptoms.

Almost exactly a year later, Devinksy and his team followed up those results with another favorable study in the same journal using a smaller dose of the drug in patients with Lennox-Gastaut. Devinsky said that low dose might be “the sweet spot” where most patients can achieve relief from symptoms without any unwanted side effects, such as drowsiness.

Also, although Epidiolex is designed to treat only two types of epilepsy, medical professionals can technically prescribe it “off-label” for other conditions as well. (The anesthetic ketamine, for example, is prescribed this way for some hard-to-treat forms of depression.)

“We would expect that once this is approved as a drug it’s quite likely this will be tried in other populations off-label so it has a big opportunity to affect others,” Lubbers said.

Epidiolex vs. other CBD products

Scientists and advocates representing families of patients with epilepsy are hailing Epidiolex’s arrival as a long-awaited treatment. But they are also aware that desperate patients – especially parents of young children – may actively seek alternate sources of CBD that may be cheaper and don’t require a doctor’s prescription.

In states where marijuana is legal (or in states with laws legalizing CBD on its own), oils and salves made with CBD are widely available. But experts caution that these products may not be what they seem.

“What’s different with [Epidiolex] is that this is a well-studied and well-controlled product,” Laura Lubbers, the chief scientific officer of a nonprofit called Cure that funds epilepsy research, told Business Insider in April.

But most dispensary-grade CBD products are not well-studied or well-controlled.

For a 2017 study published in the Journal of the American Medical Association, researchers tested 84 products purchased from 31 different online CBD sellers. Roughly seven out of 10 items had different levels of CBD than what was written on the label. Of all of the items they tested, roughly half of the items had more CBD than was indicated; a quarter had less. And 18 of the samples tested positive for THC, despite it not being listed on the label.

“The main thing is that CBD as approved by the FDA is pharmaceutical-grade CBD. It’s manufactured under stringent standards, the same as other FDA-approved drugs,” Shlomo Shinnar, the president of the American Epilepsy Society and a professor of neurology and epidemiology at the Albert Einstein College of Medicine, told Business Insider. “That’s not the same as when people tell you, ‘Oh, I’ve got marijuana and it’s high in CBD,’ or ‘Oh, I’ve got a CBD product.’”

A powerful catalyst for deeper research into cannabis-derived drugs

marijuana

source
REUTERS/Michaela Rehle

Epidiolex’s approval could also be a powerful catalyst for deeper research into other marijuana-derived medicines. Cannabis has more than 400 compounds, of which CBD and THC are only two, and researchers think the others could hold promise as well.

The drug’s green light also means that the Drug Enforcement Agency now has 90 days to reschedule CBD, which it listed in January of last year as a “marihuana extract” separate from “marihuana” or THC.

That means instead of being listed alongside marijuana as a Schedule 1 drug with “no currently accepted medical use,” CBD will soon be categorized as either a Schedule 2 or 3 drug, much like the popular ADHD medication Adderall.

“We don’t have a choice on that,” DEA public affairs officer Barbara Carreno told Business Insider. “It absolutely has to become Schedule 2 or 3.”

Once that happens, it’ll unleash what Carreno called a “sea change” for CBD manufacturers and the industry as a whole, which up until this point has existed in a legal grey area.

Apart from CBD, researchers are also actively studying THC and other marijuana compounds for a range of potential medical uses, from relieving pain to soothing severe nausea. Although Epidiolex is the first marijuana plant-based drug to land FDA approval, the agency has already given the green light to drugs whose active ingredient is a lab-made version of THC, for example.

In the meantime, experts look forward to seeing Epidiolex made available to patients in need.

“I’m not currently aware of any other major new drugs that are close to being where this drug is,” Shinnar said.

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