The U.S. Food and Drug Administration (FDA) approved a cannabis-based epilepsy medication today. The medicine, Epidiolex, is the first drug derived directly from cannabis approved by the regulatory agency.
The FDA has previously approved medications with synthetic versions of cannabinoids such as THC. But Epidiolex is the first drug containing a botanical extract from cannabis plants to receive approval.
Epidiolex is a flavored oral solution with cannabidiol (CBD) that reduces seizures in children with epilepsy. The medicine, which is not psychoactive, also contains less than 0.1 percent THC. Drug manufacturer GW Pharmaceuticals produces Epidiolex at its facilities in the U.K. After researchers found the drug effective in clinical trials, the company filed for FDA approval last year.
The FDA is currently considering approving the drug to treat Lennox-Gastaut (LGS) and Dravet syndromes, two severe forms of epilepsy. Earlier this year, an FDA advisory panel unanimously recommended approval for Epidiolex. The panel decided that the benefits of Epidiolex outweighed the risks for children two-years-old and up with LGS and Dravet Syndrome.
In an announcement of the approval, FDA Commissioner Scott Gottlieb, M.D. said that the agency is also willing to consider other medical marijuana treatments that complete the regulatory process.
“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development,” said Gottlieb.
Drug Gives Parents Hope
Dr. Elizabeth Thiele is the director of pediatric epilepsy at Massachusetts General Hospital and a professor of neurology at Harvard Medical School. She was also a primary investigator for a GW study on the effects of Epidiolex in LGS patients. She noted that Epidiolex might provide a new chance for parents struggling to provide relief for their children.
“As a physician who treats LGS and Dravet syndrome, I know that patients and their families usually face significant difficulties getting seizures under control using existing therapies,” Thiele said.
“The results from these studies suggest that this pharmaceutical formulation of cannabidiol may provide hope for a new treatment option that may be effective for some patients.”
One patient the drug has already helped is Marissa Parsons. Marissa, 21, has suffered from seizures since she was three months old. Traditional epilepsy medications were mostly ineffective and caused serious side effects. She is unable to speak and must use a wheelchair. As her condition worsened, Marissa stopped smiling.
Three years ago, she participated in a clinical trial for Epidiolex. The medicine reduced Marissa’s seizures dramatically and then, her smile returned.
Ronda Parsons, Marissa’s mother, said the medication has changed their lives.
“We can function like a typical family,” she said. “That, and her smile, mean the world to me.”
Will Approval Lead to Rescheduling Cannabis?
Currently, cannabis and all cannabinoids are Schedule 1 controlled substances. But FDA approval for a medicinal use of cannabis could lead to a rescheduling of cannabis under the Controlled Substances Act.
Justin Gover of GW Pharmaceuticals said approval is “a recognition that the plant is a rich source of compounds which have potential therapeutic activity.”
And if approval then leads to a rescheduling, it could then open the floodgates for more research and development.
“We are just scratching the surface of what could be a range of cannabis-based medications,” Gover added.
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