Epidiolex

The First Cannabis-Based Prescription Medication in the United States

Figure 1. Bottled solution of Epidiolex, the first FDA-sanctioned medical use of CBD since the classification of cannabis as a Schedule I drug.

Cannabis has been used medicinally for millennia before the arrival of Europeans on America’s shores. Therefore, it is no surprise that CBD, one of the main phytocannabinoid ingredients in C. sativa, has been successfully shown to have therapeutic effects.

Against the odds, last month a Food and Drug Administration (FDA) advisory panel recommended approval of GW Pharmaceuticals PLC’s Investigational New Drug application for Epidiolex to treat two rare forms of childhood epilepsy; Lennox-Gastaut syndrome and Dravet syndrome². This represents the first cannabis-derived prescription medication in the United States since the classification of cannabis as a Schedule I drug.

On its website the FDA asserts that it supports research into medical cannabis, and that persons can submit applications for approval of research by the FDA and the DEA¹. However, scientific researchers studying cannabidiol must meet federal security requirements and follow federal practices. Some scientists have said this has slowed research supporting medicinal benefits of cannabis³.

Lennox-Gastaut syndrome and Dravet syndrome are among the most difficult types of epilepsy to treat, with nearly all patients continuing to have seizures despite currently available medications, according to the FDA. The large number of seizures—experts say a person can have multiple episodes a day—puts children at high risk for intellectual and developmental disabilities, as well as death. Lennox-Gastaut syndrome usually appears between ages 3 and 5, and Dravet syndrome earlier.

There are an estimated 30,000 children and adults with Lennox-Gastaut syndrome and fewer than that with Dravet syndrome. Because the conditions are so rare, GW Pharmaceuticals has received an orphan drug designation for Epidiolex—which qualifies GW for several incentives in developing the drug, including tax credits.

The news about GW Pharmaceuticals is encouraging for advocates of medicinal cannabis as well as medical researchers hoping to open the doors for further cannabinoid research. In addition to Epidiolex, the FDA approved the study of Sativex—also of GW Pharmaceuticals—which contains both CBD and THC, for treatment of pain in patients with advanced cancer who experience inadequate pain-relief during optimized chronic opioid therapy⁴. Sativex is already being lauded for its therapeutic success as a novel Multiple Sclerosis (MS) treatment.

We hope that GW Pharmaceuticals continues to pave the way for further CBD clinical research, and that public pressure continues to mount on the federal government to overturn the DEA’s ludicrous classification of a therapeutic agent as a Schedule I compound, when so much mounting evidence and worldwide concensus⁵ has already been had on the subject.

References

1. https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm421163.htm
2. Kaplan, Sheila. D.A. Panel Recommends Approval of Cannabis-Based Drug for Epilepsy. New York Times. April 19 2018. Accessed May 22, 2018. https://www.cnn.com/2017/05/24/health/cannabidiol-epilepsy-study/index.html
3. https://www.nytimes.com/2018/04/19/health/epidiolex-fda-cannabis-marajuana.html
4. https://www.gwpharm.com/about-us/news/gw-pharmaceuticals-announces-sativex-receives-fast-track-designation-fda-cancer-pain
5. Cannabidiol (CBD) Pre-Review Report. Expert Committee on Drug Dependence. World Health Organization. Thirty Ninth Meeting, Agenda Item 5.2. November 6-10, 2017.