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A6 U.S. NEWS
Tuesday 26 June 2018

Medical milestone: US OKs marijuana-based drug for seizures

By MATTHEW PERRONE The immediate impact of spokeswoman said the
AP Health Writer Monday’s approval on company would not im-
WASHINGTON (AP) — U.S. these products is unclear. mediately announce a
health regulators on Mon- FDA Commissioner Scott price for the drug, which
day approved the first pre- Gottlieb suggested the it expects to launch in the
scription drug made from agency would be scruti- fall. Wall Street analysts
marijuana, a milestone that nizing CBD products with have previously predicted
could spur more research “uncertain dosages and it could cost $25,000 per
into a drug that remains ille- formulations.” year, with annual sales
gal under federal law, de- “We are prepared to take eventually reaching $1 bil-
spite growing legalization action when we see the lion.
for recreational and medi- illegal marketing of CBD- For their part, GW Pharma-
cal use. containing products with ceuticals executives say
The Food and Drug Ad- serious, unproven medical they are not trying to dis-
ministration approved the claims,” Gottlieb said in a rupt products already on
medication, called Epidio- statement. the market. The company
lex, to treat two rare forms The FDA previously issued has pushed legislation in
of epilepsy that begin in This May 23, 2017 file photo shows GW Pharmaceuticals’ warnings to CBD produc- several states to make sure
childhood. But it’s not quite Epidiolex, a medicine made from the marijuana plant but ers that claimed their prod- its drug can be legally sold
medical marijuana. without THC. ucts could treat specific and prescribed.
The strawberry-flavored Associated Press diseases, such as cancer or The FDA approval for Epid-
syrup is a purified form of a lepsy. CBD is one of more ers. Her 13-year-old daugh- Alzheimer’s. Only products iolex is technically limited
chemical ingredient found than 100 chemicals found ter, Molly, has suffered from that have received formal to patients with Dravet
in the cannabis plant — but in marijuana. But it doesn’t severe seizures since she FDA approval can make and Lennox-Gastaut syn-
not the one that gets users contain THC, the ingredi- was 4 months old. But then such claims, typically re- dromes, two rare forms of
high. It’s not yet clear why ent that gives marijuana its Hendershot learned about quiring clinical trials costing epilepsy for which there are
the ingredient, called can- mind-altering effect. a trial of Epidiolex at New millions. few treatments. But doctors
nabidiol, or CBD, reduces Physicians say it’s important York University. Most CBD producers side- will have the option to pre-
seizures in some people with to have a consistent, gov- “I preferred this to some step the issue by making scribe it for other uses.
epilepsy.British drugmaker ernment-regulated version. of those other options be- only broad claims about The new medication enters
GW Pharmaceuticals stud- “I’m really happy we have cause it’s is a commercial general health and well- an increasingly complicat-
ied the drug in more than a product that will be much product that has gone being. ed legal environment for
500 children and adults cleaner and one that I through rigorous testing,” Industry supporters down- marijuana.
with hard-to-treat seizures, know what it is,” said Dr. El- said Hendershot, who lives played the impact of the Nine states and the District
overcoming numerous le- laine Wirrell, director of the in Rochester, New York. FDA approval. of Columbia have legalized
gal hurdles that have long Mayo Clinic’s program for Since receiving Epidio- “I don’t know a mom or marijuana for recreational
stymied research into can- childhood epilepsy. “In the lex, Hendershot says her dad in their right mind use. Another 20 states allow
nabis. artisanal products there’s daughter has been able to who is going to change medical marijuana, but the
FDA officials said the drug often a huge variation in concentrate more and has what’s already working,” U.S. government continues
reduced seizures when doses from bottle to bottle had fewer “drop” seizures said Heather Jackson, to classify it as a controlled
combined with older epi- depending on where you — in which her entire body CEO of Realm of Caring, a substance with no medical
lepsy drugs. get it.” goes limp and collapses. charitable group affiliated use, in the same category
The FDA has previously ap- Side effects with the drug CBD oil is currently sold on- with Colorado-based CW as heroin and LSD.
proved synthetic versions include diarrhea, vomiting, line and in specialty shops Hemp, one of nation’s larg- Despite increasing accep-
of another cannabis ingre- fatigue and sleep prob- across the U.S., though its est CBD companies. “I re- tance, there is little rigorous
dient for medical use, in- lems. legal status remains murky. ally don’t think it’s going to research on the benefits
cluding severe weight loss Several years ago, Allison Most producers say their affect us much.” and harms of marijuana.
in patients with HIV. Hendershot considered re- oil is made from hemp, a Jackson’s group estimates Last year a government-
Epidiolex is essentially a locating her family to Colo- plant in the cannabis family the typical family using commissioned group con-
pharmaceutical-grade rado, one of the first states that contains little THC and CBD to treat childhood epi- cluded that the lack of
version CBD oil, which to legalize marijuana and can be legally farmed in a lepsy spends about $1,800 scientific information about
some parents already use home to a large network of number of states for cloth- per year on the substance. marijuana and CBD poses
to treat children with epi- CBD producers and provid- ing, food and other uses. A GW Pharmaceuticals a risk to public health.q