Earlier this week the U.S. Food and Drug Administration (FDA) approved for use Epidiolex (cannabidiol) [CBD], an oral solution containing CBD, a chemical component of the Cannabis sativa plant that does not cause the intoxication or euphoria that is produced by THC, the primary psychoactive component of marijuana. Epidiolex is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is approved for the treatment of Dravet syndrome and Lennnox-Gastaut syndrome (LGS), two epilepsy disorders that make their first appearance in early childhood and often cause profound and life-long difficulties for those suffering with the conditions.

Epidiolex was approved following three randomized, double-blind, placebo-controlled trials that included 516 patients with either LGS or Dravet syndrome. The results of the trials were published in The New England Journal of Medicine and Lancet in 2017 and 2018 and showed the Epidiolex significantly reduced the frequency of seizures in patients with LGS and Dravet syndrome.

FDA Commissioner Scott Gottlieb, M.D., issued an extensive statement regarding the approval, noting:

This product approval demonstrates that advancing sound scientific research to investigate ingredients derived from marijuana can lead to important therapies. This new treatment provides new options for patients.

This is an important medical advance. 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. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition. Moreover, this is a purified form of CBD. It’s being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits. This is how sound medical science is advanced.

Gottlieb expressed the FDA’s support for the advancement of scientific inquiry into the potential for additional medical uses of marijuana-derived drugs, but also noted the FDA’s ongoing concern with the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims. He reinforced the fact that the FDA will take action when necessary to protect consumers, stating:

The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases. The FDA has taken recent actions against companies distributing unapproved CBD products. These products have been marketed in a variety of formulations, such as oil drops, capsules, syrups, teas, and topical lotions and creams. These companies have claimed that various CBD products could be used to treat or cure serious diseases such as cancer with no scientific evidence to support such claims. We’ll continue to take action when we see the illegal marketing of CBD-containing products with unproven medical claims. We’re especially concerned when these products are marketed for serious or life-threatening diseases, where the illegal promotion of an unproven compound could discourage a patient from seeking other therapies that have proven benefits.

The FDA granted approval of Epidiolex to GW Research plc (GW), a company based in the United Kingdom, and its U.S. subsidiary, Greenwich Biosciences. Before the drug becomes available for sale, CBD must undergo de-listing as a Schedule 1 drug.  According to a press release issued by GW, the process is expected to take 90 days.

“We don’t expect to know the price until the fall, but over the coming weeks, we’ll work with setting a price with the insurance providers. We expect it to be covered by most insurers,” said Justin Gover, the chief executive officer of GW Pharmaceuticals in an interview with ABC News.

The FisherBroyles Pharmacy and Health Care Law team is pleased to keep you updated on events of interest to those in the healthcare and pharmaceutical industries. Questions regarding the subject matter of this alert may be directed to any of the following attorneys:

Brian Dickerson, FisherBroyles Partner
Brian E. Dickerson

Anthony Calamunci, FisherBroyles Partner
Anthony Calamunci

Nicole Waid, FisherBroyles Partner
Nicole Hughes Waid

Amy Butler, FisherBroyles Partner
Amy Butler