U.S. health regulators on Monday approved the first prescription drug made from cannabis, 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 is 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 is 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. FDA chief Scott Gottlieb said his agency had supported research on cannabis-derived products “for many years.”
“This approval serves as a reminder that sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” Gottlieb told reporters.
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 does not contain THC, the ingredient that gives marijuana its mind-altering effect. Physicians say it’s important to have a consistent, government-regulated version.