If eventually approved, the drug will be the first marijuana-derived medicine to get federal sanction for prescription use in the United States. A unanimous recommendation seemed all but inevitable after GW Pharmaceuticals received a favorable review for Epidiolex from FDA staff recently.
Marijuana-Based Epilepsy Drug Will Get FDA Vote In June
In June, the FDA will vote whether to approve the drug that is a strawberry-flavored oral solution, which makes sense given that it'll mostly be administered to children with Dravet syndrome and Lennox-Gastaut syndrome. The drug contains cannabidiol, the marijuana-based element in question, but it contains less than 0.1 percent of tetrahydrocannabinol, which is what causes "highness" among cannabis users.
"We're obviously very pleased by the unanimous recommendation in support of the approval of Epidiolex," said GW Pharmaceuticals CEO Justin Gover, as CNN reports. "It's a very important milestone in the approval process."
What Is Epidiolex For?
The imminent approval should serve as good news for families who have children suffering from the aforementioned epilepsy types. Dravet syndrome is marked by myoclonus-type seizures, among others, while Lennox-Gastaut syndrome is distinguished by multiple seizures and intellectual disability.
Most patients with those diseases have uncontrolled daily seizures even with treatment, putting them at high risk for developmental disabilities, serious injury, or even premature death, said FDA staff in background materials released recently.
One-third of Americans who have epilepsy have found no therapies that can effectively manage their seizures, according to the Epilepsy Foundation.
If approved, the FDA will limit prescription of Epidiolex to epilepsy patients, though doctors may be able to prescribe it "off-label" for other uses.
The FDA is free to go against the recommendation of outside advisers, but it usually follows it. If approved, the drug could pave for the way for other marijuana-based medicine as well, according to analysts.
Some parents of patients who have been participating in Epidiolex trials say the lives of their children have changed thanks to the medication.
"I had seizures for 10 years," said Sam Vogelstein during a public hearing. He's the first epilepsy patient to try Epidiolex, which he began taking five years ago. "My parents tell me there were times I had seizures 100 times a day. I've been seizure-free for more than two years now. It changed my life."