FDA approves first marijuana-based drug for seizures
British drugmaker GW Pharmaceuticals studied the drug in more than 500 Washington — U.S. health regulators on children and adults with hard-to-treat Monday approved the first prescription seizures, overcoming numerous legal hurdrug made from marijuana, a milestone dles that have long stymied research into that could spur more research into a drug cannabis. that remains illegal under federal law, deFDA officials said the drug reduced seispite growing legalization for recreationzures when combined with older epilepsy al and medical use. drugs. FDA chief Scott Gottlieb said his
The Food and Drug Administration apagency had supported research on cannaproved the medication, called Epidiolex, bis-derived products “for many years.” to treat two rare forms of epilepsy in pa“This approval serves as a reminder tients 2 years and older. But it’s not quite that sound development programs that medical marijuana. properly evaluate active ingredients con
The strawberry-flavored syrup is a putained in marijuana can lead to important rified form of a chemical ingredient found medical therapies,” Gottlieb told reporters.inthecannabisplant—butnottheone that gets users high. It’s not yet clear why The FDA has previously approved synthe ingredient, called cannabidiol, or CBD, thetic versions of another cannabis ingrereduces seizures in some people with epdient for medical use, including severe ilepsy. 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.
“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 childhood 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.