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Medical milestone: US approves marijuana-based drug for seizures

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(25 Jun 2018) Families who have used marijuana-based cannabidiol for years to treat epilepsy in their children say they’re hopeful that federal approval of a medication using the same compound will help more families.
US 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 in patients 2 years and older. 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. 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.
F amilies in states with medical marijuana have claimed cannabidiol, or CBD, helps control seizures in their children and a federal panel in April determined that Epidiolex works and is safe to treat children with Lennox-Gastaut and Dravet syndromes, two rare forms of epilepsy.
Families who moved to Colorado years ago for access to CBD hope that the federal approval of Epidiolex won’t mean the end of access to locally produced and sold CBD which they say helps their children.
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.

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