Pubdate: Wed, 20 Jun 2018
Source: Orlando Sentinel (FL)
Copyright: 2018 Orlando Sentinel
Author: Matthew Perrone


A closely watched medicine made from the marijuana plant reduces
seizures in children with severe forms of epilepsy and warrants
approval in the United States, health officials said Tuesday.

British drugmaker GW Pharmaceuticals is seeking permission to sell its
purified form of an ingredient found in cannabis -- one that doesn't
get users high -- as a medication for rare, hard-to-treat seizures in
children. If successful, the company's liquid formula would be the
first government-approved drug derived from the cannabis plant in the

The Food and Drug Administration's approval would technically limit
the treatment to a small group of epilepsy patients. 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. Man-made versions of a different marijuana ingredient have
previously been approved for other purposes.

The FDA posted its review of the experimental medication Epidiolex
ahead of a public meeting Thursday when a panel of outside experts
will vote on the medicine's safety and effectiveness. It's a
non-binding recommendation that the FDA will consider in its final
decision by late June.

Patients taking the treatment had fewer seizures, according to the
FDA's internal review posted online. Scientists concluded that GW
Pharmaceutical's submission "appears to support approval" despite some
potential side effects including risks of liver injury.

President Donald Trump has promised to support legislation protecting
the marijuana industry in states that have legalized the drug, a move
that could lift a threat to the industry made by the U.S. attorney
general just three months ago.

More than two dozen states allow marijuana use for a variety of
ailments, but the FDA has not approved it for any medical use. In
2016, the agency recommended against easing federal restrictions on
marijuana. The U.S. continues to classify marijuana as a high-risk
substance with no medical use, alongside other illicit drugs like
heroin and LSD.

For years, desperate patients and parents have pushed for wider access
to medical marijuana products for a host of conditions including pain,
post-traumatic stress disorder and epilepsy, with only anecdotal
stories and limited studies on their side.

But studies conducted by GW Pharmaceuticals have begun to change that

Across three studies involving more than 500 patients, Epidiolex
generally cut the number of monthly seizures by about 40 percent,
compared with reductions between 15 and 20 percent for patients taking
a dummy medicine.

Most patients in the study were already taking at least three other
medications to try and control their 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
U.S., though its legal status remains murky. Most producers say their
oil is made from hemp, a plant in the cannabis family that contains
little THC and can be legally farmed in a number of states for
clothing, food and other uses.

A doctor who treats children with epilepsy says it's important to have
an FDA-approved version of CBD.

"I think it needs to be approved because everyone is using it across
the internet without knowing the safety . and no one is watching the
interactions with other drugs," said Dr. Joan Conry of Children's
National Health System in Washington, who was not involved in the studies.

Conry and other researchers say it's not yet clear why CBD reduces
seizures in some patients.

GW Pharmaceuticals makes its drug from cannabis plants that are
specially bred to contain high levels of CBD. It's seeking approval
for two rare forms of childhood epilepsy -- Dravet and Lennox-Gastaut

Common side effects included diarrhea, vomiting, fatigue and sleep
problems. FDA reviewers flagged a more serious issue with potential
liver injury, but said doctors could manage the risk by monitoring
patients' enzyme levels.