Pubdate: Thu, 19 Apr 2018
Source: Times-Picayune, The (New Orleans, LA)
Copyright: 2018 The Times-Picayune


WASHINGTON -- A medicine made from the marijuana plant moved one step
closer to U.S. approval Thursday after federal health advisers
endorsed it for the treatment of severe seizures in children with epilepsy.

If the Food and Drug Administration follows the group's
recommendation, GW Pharmaceuticals' syrup would become the first drug
derived from the cannabis plant to win federal approval in the U.S.

The 13-member FDA panel voted unanimously in favor of the experimental
medication made from a chemical found in cannabis -- one that does not
get users high. The panelists backed the drug based on three studies
showing that it significantly reduced seizures in children with two
rare forms of childhood epilepsy.

"This is clearly a breakthrough drug for an awful disease," said panel
member Dr. John Mendelson, of the Friends Research Institute in
Baltimore, Maryland.

The drug carries a potential risk of liver damage, but panelists said
doctors could monitor patients for any signs. More common side effects
included diarrhea, vomiting, fatigue and sleep problems.

FDA regulators are due to make their decision by late June. Approval
would technically limit the drug, called Epidiolex, to patients with
hard-to-treat forms of epilepsy. But doctors would have the option to
prescribe it for other uses and it could spur new pharmaceutical
research and interest into other cannabis-based products.

More than two dozen states allow marijuana use for a variety of
ailments, but the FDA has not approved it for any medical use. The FDA
has approved synthetic versions of another cannabis ingredient for
other medical purposes.

Several patients and parents at Thursday's meeting spoke about the
benefits of Epidiolex. Sam Vogelstein, 16, said he experienced daily
seizures -- at times more than 100 per day-- before enrolling in a
study of the drug.

"I just went to South Africa for two weeks without my parents on a
school trip," said Vogelstein, who lives in Berkeley, California. "I
would not have been able to do that if I had not tried this

It's not yet clear why the medicine reduces seizures.

Epidiolex is essentially a pharmaceutical-grade version of
cannabidiol, or CBD oil, which some parents have used for years to
treat children with epilepsy. CBD is one of more than 100 chemicals
found in the cannabis plant and it doesn't contain THC, the ingredient
that gives marijuana its mind-altering effect.

CBD oil is currently sold online and in specialty shops across the
country, though its legal status remains murky. Most producers say
their oil is made from hemp, a form of cannabis that contains little
THC and can be legally farmed in a number of states for clothing, food
and other uses.

It's unclear how FDA approval of a CBD drug would affect products
already on the market. Executives for the British drugmaker GW
Pharmaceuticals say their goal is to provide a more standardized,
research-backed version.

"We're not looking to impact the availability of other products on the
market," GW executive Steve Schultz said before the meeting. "Our goal
is to provide an additional option for patients and physicians who
desire a purified version of CBD for treatment of seizures."

The company declined to comment on the price of the drug before the
approval decision. Wall Street analysts estimate it could cost more
than $25,000 per year.
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