Pubdate: Mon, 25 Jun 2018
Source: Hartford Courant (CT)
Copyright: 2018 The Hartford Courant
Author: Matthew Perrone


U.S. health regulators on Monday approved the first prescription drug
made from marijuana, a milestone that could spur more research into a
drug that remains illegal under federal law, despite growing
legalization for recreational and medical use.

The Food and Drug Administration approved the medication, called
Epidiolex, to treat two rare forms of epilepsy that begin in
childhood. But it's not quite medical marijuana.

The strawberry-flavored syrup is a purified form of a chemical
ingredient found in the cannabis plant -- but not the one that gets
users high. It's not yet clear why the ingredient, called cannabidiol,
or CBD, reduces seizures in some people with epilepsy.

British drugmaker GW Pharmaceuticals studied the drug in more than 500
children and adults with hard-to-treat seizures, overcoming numerous
legal hurdles that have long stymied research into cannabis.

FDA officials said the drug reduced seizures when combined with older
epilepsy drugs.

The FDA has previously approved synthetic versions of another cannabis
ingredient for medical use, including severe weight loss in patients
with HIV.

Epidiolex is essentially a pharmaceutical-grade version CBD oil, which
some parents already use to treat children with epilepsy. CBD is one
of more than 100 chemicals found in marijuana. But it doesn't contain
THC, the ingredient that gives marijuana its mind-altering effect.

A marijuana extract significantly reduced seizures in severely
epileptic children, according to a landmark study conducted in part at
Lurie Children's Hospital of Chicago.

Supporters said the results greatly improve the chances for the drug,
called Epidiolex, to win eventual approval by federal...

Physicians say it's important to have a consistent,
government-regulated version.

"I'm really happy we have a product that will be much cleaner and one
that I know what it is," said Dr. Ellaine Wirrell, director of the
Mayo Clinic's program for childhood epilepsy. "In the artisanal
products there's often a huge variation in doses from bottle to bottle
depending on where you get it."

Side effects with the drug include diarrhea, vomiting, fatigue and
sleep problems.

Several years ago, Allison Hendershot considered relocating her family
to Colorado, one of the first states to legalize marijuana and home to
a large network of CBD producers and providers. Her 13-year-old
daughter, Molly, has suffered from severe seizures since she was 4
months old. But then Hendershot learned about a trial of Epidiolex at
New York University.

"I preferred this to some of those other options because it's is a
commercial product that has gone through rigorous testing," said
Hendershot, who lives in Rochester, New York.

Since receiving Epidiolex, Hendershot says her daughter has been able
to concentrate more and has had fewer "drop" seizures -- in which her
entire body goes limp and collapses.

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.

The immediate impact of Monday's approval on these products is unclear.

FDA Commissioner Scott Gottlieb suggested the agency would be
scrutinizing CBD products with "uncertain dosages and

"We are prepared to take action when we see the illegal marketing of
CBD-containing products with serious, unproven medical claims,"
Gottlieb said in a statement.

The FDA previously issued warnings to CBD producers that claimed their
products could treat specific diseases, such as cancer or Alzheimer's.
Only products that have received formal FDA approval can make such
claims, typically requiring clinical trials costing millions.

A Georgia couple who turned to marijuana as a last resort to help
their son's "horrific" seizures has lost custody of the teen and are
facing reckless conduct charges from cops who deemed their treatment
plan "abusive."

"I don't know a mom or dad in their right mind who is going to change
what's already working," said Heather Jackson, CEO of Realm of Caring,
a charitable group affiliated with Colorado-based CW Hemp, one of
nation's largest CBD companies. "I really don't think it's going to
affect us much."

Jackson's group estimates the typical family using CBD to treat
childhood epilepsy spends about $1,800 per year on the substance.

A GW Pharmaceuticals spokeswoman said the company would not
immediately announce a price for the drug, which it expects to launch
in the fall. Wall Street analysts have previously predicted it could
cost $25,000 per year, with annual sales eventually reaching $1 billion.

For their part, GW Pharmaceuticals executives say they are not trying
to disrupt products already on the market. The company has pushed
legislation in several states to make sure its drug can be legally
sold and prescribed.

The FDA approval for Epidiolex is technically limited to patients with
Dravet and Lennox-Gastaut syndromes, two rare forms of epilepsy for
which there are few treatments. But doctors will have the option to
prescribe it for other uses.

The new medication enters an increasingly complicated legal
environment for marijuana.

Nine states and the District of Columbia have legalized marijuana for
recreational use. Another 20 states allow medical marijuana, but the
U.S. government continues to classify it as a controlled substance
with no medical use, in the same category as heroin and LSD.

Despite increasing acceptance, there is little rigorous research on
the benefits and harms of marijuana. Last year a government-commissioned
group concluded that the lack of scientific information about
marijuana and CBD poses a risk to public health.

Before sales of Epidiolex can begin, the Drug Enforcement
Administration must formally reclassify CBD into a different category
of drugs that have federal medical approval.

GW Pharmaceuticals makes the drug in the U.K. from cannabis plants
that are specially bred to contain high levels of CBD. And the company
plans to continue importing the medicine, bypassing onerous U.S.
regulations on manufacturing restricted substances.
- ---
MAP posted-by: Matt