April 19 (UPI) — A Food and Drug Administration’s advisory committee on Thursday unanimously approved an experimental drug made from marijuana to treat seizures associated with two rare forms of epilepsy in children.
By a 13-0 vote, the Peripheral and Central Nervous System Drugs Advisory Committee approved Epidiolex, the first plant-derived cannabidiol medicine for prescription use in the United States.
Synthetic forms of chemicals derived from marijuana have previously been approved for other purposes, including cancer pain relief.
Earlier this week, the FDA’s staff endorsed Epidiolex to treat Dravet syndrome and Lennox-Gastaut syndrome, rare forms of epilepsy most resistant to other treatment that affect children 2 years of age and older.
The panel of independent experts approved the drug, which will be available in syrup with strawberry flavoring, after receiving clinical trial data from GW Pharmaceuticals PLC, a British-based biopharmaceutical company.
The recommendation next goes to the FDA’s Center for Drug Evaluation and Research for final review, and GW Pharmaceuticals said it is hoping for the completion of the New Drug Application review of the cannabidiol oral solution by June 27.
“We are pleased by the Advisory Committee’s unanimous recommendation to approve Epidiolex, which would provide an important treatment option for patients with LGS and Dravet syndrome, two of the most severe and treatment-resistant forms of epilepsy,” Justin Gover, GW’s chief executive officer, said in a press release.
Cannabidiol, also called CBD, does not produce a high, unlike tetrahydrocannabinol, or THC. CMD contains less than 0.1 percent of THC.
“Although CBD is a cannabinoid, it shares almost none of the pharmacologic features of the prototypical cannabinoid,” the FDA committee staff wrote, noting that the drug “has significantly less abuse potential” than two other forms of cannabis: THC given as 2 doses of dronabinol or a single dose of alprazola, or ALZ.
The acceptable safety risks included liver injury, which it said can be managed and monitored. Other epilepsy drugs have side effects.
If the drug is approved for epilepsy, Epidiolex, would need to be prescribed “off-label” for other uses.
LGS typically occurs between ages of 3 to 5 years and dravet syndrome is a condition that develops in infants.
“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,” said Dr. Elizabeth Thiele, director of pediatric epilepsy at Massachusetts General Hospital and a primary investigator for a study in LGS patients. “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.”