The first FDA-approved, marijuana-based drug is now available across the U.S., according to a release from GW Pharmaceuticals.
The drug, Epidiolex, contains cannabidiol (CBD), which is derived from marijuana, according to the Drug Enforcement Administration.
While the drug is based from cannabis, it will not cause “the high” that is associated with marijuana, the U.S. Food and Drug Administration said. That’s because it is THC — not CBD — that is the “primary psychoactive component of marijuana.”
The oral solution is approved for treating seizures associated with severe epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. The FDA approved it this June for patients who are 2 or older, according to a statement from the department.
“This is the first FDA-approved drug that contains a purified drug substance derived from marijuana,” the department said in June. “It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.”
Lennox-Gastaut syndrome and Dravet syndrome are “two of the most difficult-to-treat forms of childhood-onset epilepsy,” Justin Gover, CEO of GW Pharmaceuticals, said in the company’s release.
The CBD in the drug is highly purified, according to GW Pharmaceuticals.
“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,” FDA Commissioner Scott Gottlieb said in a statement.
The Department of Justice and DEA have classified Epidiolex as a drug in schedule V of the Controlled Substance Act, which means it has a lower potential for drug abuse. Marijuana, on the other hand, is in schedule I. That means it has “no currently accepted medical use and a high potential for abuse.”
The DEA said that when marijuana or CBD has a “medically approved benefit,” the drug will be made available for medical use.
“DEA will continue to support sound and scientific research that promotes legitimate therapeutic uses for FDA-approved constituent components of cannabis, consistent with federal law,” Acting DEA Administrator Uttam Dhillon said in September. “DEA is committed to continuing to work with our federal partners to seek ways to make the process for research more efficient and effective.”