On Monday, the Food and Drug Administration approved the first marijuana-based drug in the United States. The drug Epidiolex includes high levels of the cannabinoid Cannabidiol (CBD) and is approved to treat two rare forms of epilepsy.
Before GW Pharmaceuticals can sell the product publicly, the Drug Enforcement Administration must reschedule CBD, which is currently considered a nonmedical, dangerous, and addictive Schedule 1 narcotic. The DEA is expected to reschedule CBD within 90 days.
"This approval is the culmination of GW's many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine," GW CEO Justin Gover said in a statement. "These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician's care."
The approved forms of epilepsy, Lennox-Gastaut and Dravet syndromes, usually become present at a young age and can cause dozens of debilitating seizures each day. Epidiolex is approved for patients ages two and older and, while there are numerous approved drugs for Lennox-Gastaut, it's the first FDA-approved drug for Dravet syndrome.
"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 FDA Commissioner Scott Gottlieb, M.D. "Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA's drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients."
The FDA has previously approved synthetic versions of THC, which are listed as Schedule II and Schedule III drugs, meaning they have the potential to be addictive but also have medicinal value, like Oxycodone and Codeine.
If CBD is rescheduled, it could mean trouble for small CBD companies that advertise unresearched claims.
"We'll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims."
"This is an important medical advance," Gottlieb said. "But it's also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use."
Either way, it's a win for the cannabis industry.
A list price for Epidiolex has not yet been decided.