Marijuana drug for epilepsy, Epidiolex, gets DEA approval

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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

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.