FDA OKS pot-derived prescription drug for epilepsy

WASHINGTON — 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 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. FDA chief Scott Gottlieb said his agency had supported research on cannabis-derived products “for many years.”

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.

FDA’S Gottlieb warned about the use of other CBD products with “unproven medical claims.”

“The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases,” Gottlieb said.

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 effective treatments. Patients experience frequent, severe seizures, in some cases more than 100 per day.

But doctors will have the option to prescribe it for other uses.