Indopedia All Things Marijuana
In a statement, the FDA noted that Epidiolex is “The first FDA-approved drug that contains a purified drug substance derived from marijuana.” The agency explained that the drug contains CBD, and not THC, and is hence not psychoactive in any way. The FDA has previously approved three other marijuana-based medicines – marketed as Marinol, Cesamet, and Syndros – but all three of these are created from synthetic, lab-prepared cannabinoids, not actual cannabis plants themselves.
“The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients’ quality of life,” said Billy Dunn, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition.”
“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. “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.”
While the DEA still classifies all other cannabis-derived medicines as Schedule I drugs with no medical value, the agency will have to choose a different schedule for Epidiolex now that the FDA has approved its medical use. The agency is expected to make this classification within 90 days. Gottlieb made it clear that the FDA’s approval of Epidiolex does not mean that all CBD-based medicines are now legal, however.
“This is an important medical advance,”
The commissioner also noted that his agency is “prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. “However, it remains to be seen whether physicians will be comfortable prescribing this new agent to those patients who may benefit from it, and whether it will be priced in a range that patients may afford. ” The actual list price of Epidiolex has not been set, but has been estimated at $2,500 to $5,000 a month, significantly more expensive than other CBD-based medication made available through state-legal medical cannabis programs. “Nonetheless, these alternatives should not be regulated as options to replace the use and regulation of herbal cannabis – a product that humans have used safely and effectively as a medicine for thousands of years and is approved today by statute in 30 states.
