The Food and Drug Administration advisory committee has unanimously recommended approval of a CBD treatment for epilepsy. If the FDA votes in June to give the new drug full approval, it will mark the first time a plant-derived cannabidiol medicine has been approved for prescription use in the United States.
CNN reports that the drug, called Epidiolex, helps prevent seizures in patients with epilepsy. It received approval after the committee reviewed data provided by the drug’s maker, UK-based GW Pharmaceuticals PLC.
CBD, unlike tetrahydrocannabinol (THC) doesn’t produce a high. It often used to treat anxiety, vomiting, nausea, psychotic disorders, and numerous other ailments. Epidiolex, however, would only receive official approval for treating epilepsy – although doctors could also prescribe it for other issues as well.
GW CEO Justin Gover had this to say about the committee’s decision, “We’re obviously very pleased by the unanimous recommendation in support of the approval of Epidiolex. It’s a very important milestone in the approval process.”
Successes and Side Effects
The drug was used to treat several different forms of epilepsy, including Dravet syndrome, Lennox-Gastaut syndrome, and tuberous sclerosis complex and infantile spasms.
While the early results are encouraging, there are still concerns. There are potential side effects, particularly when used with other drugs. Early study results have shown no severe liver injuries or deaths related with liver injury, but scientists feel there could be some issues for patients down the line.
Still, the risk may be worth it for patients with severe seizures. Sam Vogelstein, a 16-year-old Berkeley resident, reported that he had over 100 seizures a day prior to taking Epidiolex. “”I’ve been seizure-free for more than two years now. It changed my life.”
Gover sees this as a major step forward. “It’s a breakthrough in the field of epilepsy,” he said. “It’s the first cannabis-based pharmaceutical to be approved by the FDA. It’s the first in a new class of treatments with a new mechanism of action against epilepsy.”
The FDA will vote on whether or not to approve Epidiolex this June.