FDA Approves CBD-Based Epidiolex
The Food and Drug Administration approved GW Pharmaceuticals’ cannabidiol-based medication Epidiolex on Monday, according to the Washington Post. It is the first cannabis-based medication to be federally allowed in the United States.
Epidiolex is an oral solution that utilizes CBD and was designed to treat two severe but rare forms of epilepsy. The drug was approved for patients who are at least two years old and must be prescribed by a physician.
“Today’s approval of EPIDIOLEX is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies. 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. 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.” — Justin Gover, GW Pharmaceutical’s Chief Executive Officer, in a press release
“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, in a press release
Gottlieb said this move was not a blanket approval of medical cannabis, but just one specific drug containing CBD, an increasingly popular cannabinoid with many demonstrated medicinal benefits. Gottlieb added that the FDA has become concerned by “the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims,” a not-so-subtle reference to the country’s burgeoning hemp-based CBD industry.
Despite the FDA’s approval, the cannabis plant remains a Schedule 1 substance under the Controlled Substances Act with “no known medical applications.” With the FDA’s approval secured, however, the DEA is reportedly expected to reclassify cannabidiol within 90 days.