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A ruling is imminent on the legality of a controversial drug that’s used to treat addiction — but some have called it a ‘dangerous opioid’

A ruling is imminent on the legality of a controversial drug that’s used to treat addiction — but some have called it a ‘dangerous opioid’

Kratom is often ground into a fine powder put into capsules.

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Kratom is often ground into a fine powder put into capsules.
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  • Government regulators are expected to soon rule on the legality of a controversial drug called kratom, a representative at the Drug Enforcement Administration told Business Insider on Tuesday.
  • While federal agencies have called kratom a dangerous opioid, advocates say it’s saved their lives.
  • One thing missing from the debate about kratom: hard science on how it works.
  • For the first time this summer, a researcher isolated kratom’s two key ingredients to see how they affect behavior in rats. Although the results were preliminary, they suggested the drug could hold promise for people with addiction.

A final decision on the legality of a controversial drug is expected imminently from the US government.

The drug, called Kratom, has pitted government regulators against scientists and advocates. The Food and Drug Administration has called it a dangerous opioid and sought to ban it by making it a Schedule 1 drug like heroin or ecstasy. Some advocates say it’s helped them end their addiction to opioids, and scientists want to keep exploring its potential as a medical treatment.

Right now, researchers at the DEA are evaluating the two main components in kratom. They’ll either rule the same for both ingredients, effectively banning all forms of kratom nationwide, or they’ll ban one and make the other potentially available as a medicine at a later date. That’s according to Melvin Patterson, a spokesperson with the Drug Enforcement Administration who described the ruling as forthcoming.

“I think there’s just a few remaining in-house things the DEA was looking at” before issuing a ruling, Patterson told Business Insider on Tuesday.

Right now, kratom is legal in most states, where it is sold in whole plant form as a supplement.

The ruling is highly anticipated by both advocates who say the drug has saved their lives and by scientists who simply want to learn more about how it works.

“I wish there was some sort of holding box we could put drugs like this in until more studies could be done,” Scott Hemby, a professor of pharmaceutical science at North Carolina’s High Point University who authored a recent study isolating kratom’s two main ingredients, told Business Insider on Monday. Read more: A mysterious supplement has a viral following of people who take it for addiction – and researchers say it’s too compelling to ignore

Hemby’s research – the first of its kind – was a preliminary study looking at how kratom’s two main components affect behavior in rats. His findings suggested that the chief compound in the plant could potentially offer therapeutic benefits to people dealing with addiction, but it’s still early days for the work.

“We’re at the precipice of something promising here,” Hemby said when the paper came out.

But Hemby worries that the government’s ruling could make studying the plant and its key ingredients even harder than it already is, and he’s not alone.

Life-saving supplement or dangerous opioid?

Kratom pills.

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Kratom pills.
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Psychonaught/Wikimedia Commons

Frequently ground into a fine powder and taken as pills or tea, kratom is a psychoactive drug derived from the leaves of an Asian plant in the coffee family called Mitragyna speciosa. Kratom advocates swear by the stuff, saying it’s helped them kick devastating addictions to opioid painkillers.

But federal regulatory bodies like the FDA and the DEA have cracked down on kratom and previously tried to ban it.

“It’s like a cruel joke that I finally found something that works, and the FDA and DEA want it banned,” Bryce Avey, a 26-year-old California native told Business Insider this summer. Avey said he took kratom daily as a tea to help him stop using the opioids he became addicted to after wrist surgery.

The efforts to make kratom illegal culminated at two recent points: In 2016, the DEA attempted to ban kratom but stopped after facing backlash from advocates and members of Congress. Then in October 2017, the FDA broke out kratom’s two main components and studied them separately, ultimately recommending a ban on both of them, Stat News reported this month.

That 2017 FDA recommendation was then sent to the DEA, which began the lengthy process of reevaluating the drug’s two components to make a final decision on the legality of each of them, Patterson said.

Now, a decision on the drug’s two compounds is imminent, he said. While the FDA focuses on medicinal potential, the DEA looks at the compounds’ abuse potential.

Importantly, the agency could choose to rule differently on each compound, Patterson added. Those include mitragynine (MG) and 7‐hydroxymitragynine (7‐HMG) – two ingredients that Hemby calls “the yin and yang of kratom” because while HMG could be potentially harmful, MG seems like it has a lot of therapeutic potential.

That means that even if HMG gets banned or placed into Schedule 1, there’s a possibility that MG could be placed in a different schedule. (Popular ADHD drug Adderall, for example, is a Schedule 2 drug.)

‘The yin and yang of kratom’

In stark contrast to what regulators have said about kratom, a growing cluster of physicians and researchers are beginning to suggest that the drug could have therapeutic potential. Some have said they understand why people looking to get off opioids might find the drug helpful; others have said that new research suggests the plant’s compounds could have untapped potential.

“It makes sense that this product would mitigate the symptoms of opioid withdrawal or allow someone to transition from a higher dose to lower dose, or help get off them off of opioids altogether,” David Juurlink, a professor of medicine at the University of Toronto, told Business Insider this summer.

One big reason is that the kratom plant’s two main ingredients – which can be thought of as similar to how marijuana contains both THC and CBD – appear to have very different effects on the brain.

Of kratom’s two chief ingredients (MG and HMG), MG is thought to be the compound with the most therapeutic potential. There’s about 30 times more MG in Kratom than there is HMG.

Hemby’s study was the first to use rats to investigate how each of these two compounds affects the brain. After giving the animals the chance to self-administer each ingredient by pushing a dial, they found that the rats quickly took advantage of the opportunity to give themselves the HMG but were completely uninterested in MG.

“We stood on our heads to get them to self-administer,” Hemby said, adding that his team tried upping the doses of MG several times. “It just wasn’t working. It was almost like it was innocuous.”

In other words, while one of kratom’s main compounds appeared to be addictive, the other wasn’t at all – in fact, it appeared to have the opposite effect.

That could be promising for people who are turning to kratom for relief from opioid addiction. The drug is known to tap into some of the same brain receptors as opioids – which spurred the FDA to officially call it an opioid in February.

But some people believe those characteristics mean kratom could help treat opioid addiction by staunching cravings and reducing withdrawal and relapse.

Hemby’s findings also suggest there might be a way to process kratom to capitalize on this therapeutic potential by heightening the effects of one compound while minimizing the effects of the other. Strains of the plant, for example, can be bred to have differing concentrations of MG and HMG.

That’s something that he and other researchers like him want to keep studying, he said, so long as government regulators let them.

“It’s really a rush to judgement to say let’s put the kibosh on everything,” Hemby said.

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 first marijuana-based prescription drug in the US has been approved, and some cannabis startups should be worried

The first marijuana-based prescription drug in the US has been approved, and some cannabis startups should be worried

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  • This week’s historic decision by the Food and Drug Administration to approve Epidiolex, the first prescription drug derived from marijuana, has left cannabis startups in a tough spot.
  • Although many welcome the approval as a sign of the growing recognition of marijuana’s potential health benefits, some also worry that it will increase consumer demand for sub-par products that don’t meet basic manufacturing standards.
  • “Some of these companies are going to be great and truly add value to the consumer and some of these companies are going to be terrible and their primary focus is going to be for profit,” one startup CEO told Business Insider.

This week’s historic decision by the Food and Drug Administration to approve Epidiolex, the first prescription drug derived from marijuana, has left cannabis startups in a tough spot.

Made by GW Pharmaceuticals, the drug treats two rare types of epilepsy using CBD, a therapeutic compound in cannabis that’s not linked with a high. The new approval is already ushering in a wave of renewed interest in the potential health benefits of marijuana’s many compounds, from CBD to THC – the plant’s other well-known ingredient and the one linked with a high.

But not all marijuana-derived products are created equal.

As a prescription drug, the ingredients in Epidiolex are subject to thorough testing and federal regulation; its CBD is known as “pharmaceutical grade.”

Other marijuana products are not necessarily subject to these standards, or even basic stipulations that ensure cleanliness and proper ingredient concentrations. That worries cannabis company executives who try to ensure their products are safe and high quality.

“I believe there is going to be an even larger emergence of CBD [and other marijuana] companies touting their

as beneficial and using this approval as their basis, ” said Kelvin Harrylall, the CEO of the CBD Palace, which audits CBD companies and creates a list of vendors it deems safe for customers. “Some of these companies are going to be great and truly add value to the consumer and some of these companies are going to be terrible and their primary focus is going to be for profit.”

Exposing products in tricky legal terrain with little government oversight

cbd oil product lineup

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In states where marijuana has been legalized, thousands of cannabis startups sell pens, oils, and edibles that contain either CBD, THC, or both ingredients.

But now that CBD-containing Epidiolex has been approved, the Drug Enforcement Administration (DEA) has 90 days to reclassify CBD from something with “no recognized medical use” to a Schedule 2 or 3 drug like the ADHD medication Adderall.

Once that happens, marijuana startups will be able to sell their CBD-only products even in states where marijuana is illegal – as long as they register them with the DEA. Barbara Carreno, a DEA public affairs officer, told Business Insider that shift will represent a “sea change” for CBD companies.

For now, companies in states where marijuana or CBD is legal have the freedom to continue selling their products with little federal oversight while they benefit from the increased attention and legitimacy that Epidiolex’s approval lends them. This lack of regulation has led to wide variation in content, safety, and pricing of products that contain either CBD, THC, or both.

For a 2017 study published in the Journal of the American Medical Association, researchers tested 84 CBD products purchased from 31 different online retailers. Roughly seven out of 10 items had different levels of CBD than what was written on the label. Of all of the items tested, roughly half 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.

Giving renewed recognition to companies using science to validate their products

Still, some marijuana companies – especially those that focus on its medical applications and prioritize thorough scientific research – are excited by the approval and believe it will raise awareness of the benefits of the many compounds in the plant.

“It’s a big milestone for the industry and one that will have a massive impact on medical companies like us,” Aras Azadian, the CEO of Avicanna, a Toronto-based biotech company focused on medical cannabis, told Business Insider, adding that the decision “further validates cannabinoids and medial cannabis applications.”

Azadian is also planning to seek FDA approval for some of his company’s CBD products, which it plans to sell in the US. Last year, Azadian became the first marijuana startup to join the Johnson & Johnson JLabs Innovation network, an ecosystem designed to give budding companies access to the resources and leadership they need to get off the ground.

Other CBD companies – and groups that represent them – also see the decision in a positive light, saying that people who’ve found a CBD product that appears to offer results won’t suddenly want to switch to a new one. That may be especially true for parents of kids with the types of epilepsy that Epidiolex is designed to treat, and who’ve had success using other CBD products.

“I don’t know a mom or dad in their right mind who is going to change what’s already working,” Heather Jackson, the CEO of Realm of Caring, a charitable group linked with CBD company CW Hemp, told the Associated Press. “I really don’t think it’s going to affect us much.”

That remains to be seen.

“I believe if you are a CBD manufacturer and you can say that you’re making a quality product, from the farm your product is grown in … to the team that is working to package, bottle, and support the product … then you have nothing to worry about,” Harrylall said. “But if you aren’t sure [or] if you’ve cut corners, those CBD manufacturers are the ones that should be worried.”

There’s a sea change coming for the $1 billion marijuana-based industry you’ve never heard of

There’s a sea change coming for the $1 billion marijuana-based industry you’ve never heard of

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  • Change is coming for a small but blooming corner of the marijuana industry.
  • Cannabidiol, or CBD, is a marijuana compound that has been linked to a range of potential health benefits but does not get you high.
  • The roughly $1 billion CBD industry is slated to shift into high gear if the federal government approves the first CBD-based drug, an epilepsy medication called Epidiolex.

Change is coming for a small but blooming corner of the marijuana industry.

A compound in marijuana that’s been linked to a range of potential health benefits – but doesn’t cause a high – is increasingly being eyed for use in salves, oils, balms, and beverages. It’s also the active ingredient in a new drug that’s on the cusp of federal approval.

Cannabidiol, or CBD, is estimated to make up a roughly $1 billion industry. If and when the Food and Drug Administration approves the new CBD-based drug – a decision currently slated for the end of June – it will turn the compound into one that can be legally prescribed by a doctor.

That approval will also jump-start demand for products that have not been federally reviewed, opening up a huge opportunity for retailers and manufacturers to either work alongside the new regulations or take advantage of the legal grey area in which they’re currently operating.

The move could unleash what Drug Enforcement Administration public affairs officer Barbara Carreno called a “sea change” for the existing market of less expensive but untested and potentially risky CBD products, such as those sold in convenience stores and marijuana dispensaries.

The drug that could revolutionize the CBD market

epidiolex gw pharma

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Courtesy GW Pharmaceuticals

Since at least 2017, drug company GW Pharmaceuticals has been presenting strong research data to suggest that its CBD-based medicine, a syrup called Epidiolex, can treat the symptoms of two rare forms of childhood epilepsy that are characterized by violent seizures (known as drop seizures).

Although the Food and Drug Administration is not slated to make a final decision on the drug’s potential approval until June 27, experts say an official green light is likely.

“This is clearly a breakthrough drug for an awful disease,” John Mendelson, a panel member and senior scientist at the Friends Research Institute, said during a public pre-approval meeting to discuss the drug’s scientific benefits in April.

Orrin Devinsky, a neurologist at New York University Langone Health and a lead author on some of the GW Pharmaceuticals studies, told Business Insider, “I’d personally be very surprised if this drug was not approved.”

If Epidiolex is approved, the DEA has 90 days to shift the classification of marijuana-derived CBD from the current categorization as something with “no recognized medical use” to either a Schedule 2 or 3 drug, much like the popular ADHD medication Adderall.

Once that happens, “all the [CBD] manufacturers have to be registered with us,” Carreno said. “That’s going to make a huge difference to the industry.”

A legal grey area with unregulated products that range from teas to dog treats

cbd oil product lineup

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But for now, thousands of CBD products exist in legal limbo.

That’s because there are two main sources of CBD: marijuana (which includes the leaves of the plant), and hemp (just the stalks and sterile seeds).

While marijuana-derived CBD is only legal in the 28 states plus Washington, DC where marijuana has been legalized (as well as the 15 states where CBD alone has been legalized), hemp-derived CBD falls under a sizeable legal loophole: it is exempted from DEA regulation according to a 2006 law.

But there’s a lot of confusion in the space about which CBD products are legal or not. That’s made some CBD manufactuers skittish about selling products outside of states where marijuana is legal.

Even so, plenty of other CBD companies are looking to expand across the country, reasoning that because their products are hemp-derived, they’re legally in the clear.

Denver-based company Phoenix Tears recently signed an agreement with MarketHub Retail Services, a distributor that works with 7-Eleven franchisees, to get its hemp-derived CBD products in up to 4,500 stores by the end of this year.

“This agreement confirms our belief that CBD’s status as a mainstream wellness option has arrived,” Phoenix Tears founder Janet Rosendahl-Sweeney said in a recent statement.

Regardless of where the product comes from, there’s another pressing issue facing the CBD industry. The products are poorly regulated, and so there is wide variation in content, safety, and price.

For a 2017 study published in the Journal of the American Medical Association, researchers tested 84 CBD products purchased from 31 different online retailers. Roughly seven out of 10 items had different levels of CBD than what was written on the label. Of all of the items tested, roughly half 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.

“I’ve seen a lot of dirty CBD manufacturing facilities,” said Kevin Harlyall, the CEO of a company called the CBD Palace that audits CBD companies and creates a list of vendors it deems safe for customers. “It’s tough to know what you’re getting.”

According to the DEA, the approval of Epidiolex could change all of that.

“This is going to be a sea change if they approve it,” said Carreno.

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