The Atlanta Journal-Constitution
1ST MARIJUANA-BASED DRUG: WHAT IT WILL BE TREATING
Epilepsy treatment does not make those who use it high.
U.S. health
WASHINGTON — regulators on Mo n day 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 Admin- istration approved the med- ication, called Epidiolex, to treat two rare forms of epilepsy that begin in child- hood. 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 canna- bidiol, 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-totreat seizures, overcoming numerous legal hurdles that have long stymied research into cannabis.
FDA officials said the drug reduced seizures when com- bined with older epilepsy drugs.
The FDA has previously approved synthetic versions of another cannabis ingredi
ent 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 mari- juana. But it doesn’t contain THC, the ingredient that gives marijuana its mind-altering effect.
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 child- hood 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 relo- cating her family to Colo- rado, one of the first states to legalize marijuana and home to a large network of CBD producers and provid- ers. Her 13-year-old daugh- ter, 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 formulations.” “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. Most CBD producers sidestep the issue by making only broad claims about general health and well-being.