An experimental drug derived from cannabis to treat epilepsy is on the brink of becoming the first of its kind to win US government approval.
On Thursday, a panel of outside experts convened by the Food and Drug Administration voted unanimously in favor of the drug’s safety and effectiveness. Their recommendation will play a key role in the FDA’s approval decision for the drug, which is made by GW Pharmaceuticals.
If the FDA gives final approval — a decision is expected in June — the new drug would be sold under the name Epidiolex as a syrup. It would be the first drug whose active ingredient is cannabidiol, the compound in marijuana thought to be responsible for many of its therapeutic effects.
Cannabidiol, or CBD, doesn’t contain THC, marijuana’s main psychoactive ingredient, and is not linked with euphoria or the drug’s characteristic high. CBD appears to help reduce seizures, at least in two of the hardest-to-treat forms of epilepsy, known as Lennox-Gastaut syndrome and Dravet syndrome. That’s according to two large clinical trials the FDA considered Tuesday ahead of the vote.
GW Pharma’s long road to FDA approval
Courtesy GW Pharma
In the absence of a research-backed drug, some desperate parents of children with epilepsy have turned to CBD oils and other CBD-based products at dispensaries — but most of those are not heavily regulated.
Laura Lubbers, the chief scientific officer of a nonprofit called Cure that funds epilepsy research, told Business Insider her group saw GW’s drug as a “long-awaited” treatment. That’s especially true for patients who haven’t responded to other drugs.
“What’s different with this drug is that this is a well-studied and well-controlled product,” Lubbers said.
Because GW Pharmaceuticals was able to show that its product addresses a critical need, it was able to apply for a