The FDA recently announced its approval of GW Pharmaceutical’s Epidiolex drug, described as the first ever plant-derived cannabinoid medicine in the United States. The announcement notes that Epidiolex contains a highly purified form of cannabidiol (CBD), one of many cannabinoids derived from cannabis plants. CBD, however, lacks the psychoactive properties of its more famous cousin, tetrahydrocannabinol (THC). The FDA approved the use of Epidiolex for the treatment of seizures associated with several rare forms of epilepsy in patients 2 years and older.

According to public databases, GW Pharmaceuticals is the listed assignee of seven issued patents for methods of treating various epileptic and other medical conditions using CBD, as well published filings in Europe, Canada, Japan, and the United Kingdom.

Although CBD is an active ingredient of an FDA approved drug, CBD is still considered a Schedule 1 controlled substance under the federal Controlled Substances Act and cannot yet be placed for sale on the market. As a part of its approval of Epidiolex, the FDA has sent a recommendation to the Drug Enforcement Agency to reschedule CBD to a less-controlled schedule. The DEA must act on this recommendation within 90 days of the original approval, although the DEA is not under any obligation to reschedule marijuana or any of its components, including CBD. Nevertheless, observers have noted that the FDA’s approval of a CBD-based drug is at odds with the requirement that a Schedule 1 substance have “no currently accepted medical use in treatment.”

In a press release issued the same day as the approval of Epidiolex, the FDA Commissioner Scott Gottlieb, M.D. stressed that the approval was not a recognition of cannabis or any of its components as medicines. The press release notes that approval of Epidiolex was based on controlled clinical trials evaluating a highly purified form of CBD for treatment of specific conditions, manufacturing under consistent quality controls, and the creation of a reliable dosage form. Nevertheless, the Commissioner encouraged continued clinical research into cannabis related drugs and noted programs and guidances intended to facilitate and expedite development and review of drugs to address unmet medical needs.

Written by: Mark E. Davis