marijuana cannabis FDA
Can GW Pharma get there with Epidiolex?

In previous posts we’ve discussed the process for FDA approval of cannabis drugs. Today’s topic is GW Pharmaceuticals, a British biotech company focusing on prescription cannabinoid medicines, including developing and commercializing pharmaceutical products which address clear unmet needs.

GW Pharmaceuticals was founded in the UK in 1998 by two British biotech entrepreneurs, Dr. Geoffrey Guy and Dr. Brian Whittle. The Company is well known to many in the cannabis industry, because it was able to obtain UK licensing for broad pharmaceutical research and development into cannabis and its active compounds, including delivery methods other than smoking.

One of GW Pharmaceuticals’ first products was Sativex, an oral mucosal spray containing the cannabinoids CBD and THC, indicated as a treatment for spasticity due to multiple sclerosis. Sativex is available by prescription in the UK, EU, Canada, New Zealand and Israel. It is not approved in the United States.

GW Pharmaceuticals is now focusing on FDA approval of its liquid formulation of pure plant-derived CBD, called Epidiolex. Conditions for which Epidiolex is initially being tested are severe epilepsy syndromes including Dravet syndrome, Lennox-Gastaut syndrome, Tuberous Sclerosis Complex, and Infantile Spasms. GW Pharmaceuticals has obtained Orphan Drug and Fast Track designations from the FDA for research on Dravet syndrome. Phase 3 trials for efficacy and monitoring of adverse reactions have already shown positive effects in reducing certain seizure types from patients taking Epidiolex.

As part of its rulemaking process, FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will hold a public meeting on April 19, 2018 to consider the New Drug Application (“NDA”) submitted by GW for Epidiolex. This will include oral presentations from the public, and will be webcast. We encourage any aspiring FDA applicants in the CBD space to watch the presentations.

GW Pharmaceuticals has also recently received Notices of Allowance for five new Epidiolex patent applications that will be listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) if the NDA for Epidiolex is approved. These patent claims cover methods of treatment of treatment-resistant epilepsy with CBD oil, sometimes in combination with other compounds.

Besides Epidiolex and Sativex, GW Pharmaceuticals continues research and development on cannabidivarin, known as CBDV. Currently, Phase 2 trials for efficacy and side effects are underway for CBDV as a treatment for epilepsy, and Phase 1 trials for safety and dosage are underway using CBDV for autism spectrum disorders. Also in GW Pharmaceuticals’ R & D pipeline are Phase 1 and 2 cannabinoid studies for neonatal hypoxic-ischemic encephalopathy, glioblastoma, and schizophrenia.

Without a doubt, GW is in the vanguard of cannabis biotech companies. It now employs over 500 researchers, who have conducted over 50 Phase 2 and 3 clinical trials on cannabis-based compounds. GW has shown that it can develop and acquire regulatory approval for a cannabis pharmaceutical (Sativex) outside of the U.S., and develop a commercial market for this product.

GW Pharmaceuticals has also had great success so far with the FDA, taking its Epidiolex drug from Investigational New Drug Application to New Drug Application in less than four years. Interestingly, GW Pharmaceuticals has stated that if and when the FDA approves the NDA, it will seek to have it categorized as a Schedule IV drug under the Controlled Substances Act. Schedule IV is defined as drugs with a low potential for abuse and low risk of dependence. Currently, the lowest schedule designation of a cannabis drug is for Marinol, which is Schedule III. (A synthetic THC drug, Syndros, was recently moved to Schedule II).

Regardless of how Epidiolex might be scheduled, its potential approval by the FDA would be a major step forward for cannabis pharmaceuticals. Be sure to tune in on April 18 for further developments.