The FDA Just Approved Its First-Ever Cannabis-Based Drug
For thousands of years, cannabis has been used to treat everything from pain to indigestion.
Now, it is finally making its pharmaceutical debut, potentially opening the door for further marijuana-based treatments.
On Monday, the Food and Drug Administration announced the approval of Epidiolex, a cannabidiol (CBD) solution, to treat seizures in two rare forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. CBD is a member of the cannabinoid family, a group of chemicals produced by marijuana and other cannabis plants. Epidiolex is the first cannabis-based drug ever approved by the FDA.
Epidiolex is the first cannabis-based drug ever approved by the FDA.
The FDA approval was nearly guaranteed after a panel unanimously approved the drug earlier this year, and it comes after a six-year effort propelled by patients and families, with the support of their doctors. The first American patient tried the drug independently, and went from having days with over 100 seizures to a handful of seizures per day. His success allowed more patients to get access, followed by a randomized clinical trial.
“The power of this story is the power of the patient community,” said Elizabeth Thiele, director of pediatric epilepsy at Massachusetts General Hospital.
Unlike its fellow cannabinoid tetrahydrocannabinol (better known as THC), CBD won’t get you high. The active ingredient in strawberry-flavored Epidiolex is 99% pure CBD, extracted from cannabis grown by GW Pharmaceuticals in the United Kingdom. No one is entirely sure how the drug works, but it is thought to influence signalling between neurons. It’s a similar approach taken by other, more traditional anti-seizure medications, but through a different mechanism, said Orrin Devinsky, director of NYU Langone’s Comprehensive Epilepsy Center and leader of the clinical trial.
Epidiolex is anticipated to be available in the fall of 2018, but it isn’t quite ready for prime