GW’s Epilepsy Clinical Program
GW is committed to developing new medicines to treat rare, treatment-resistant epilepsy conditions where there are limited or in some cases, no approved treatment options.
Cannabidiol (approved as Epidiolex® in the United States) is GW’s lead cannabinoid product is a proprietary oral solution of highly purified plant-derived cannabidiol, or CBD. GW’s Epidiolex development has initially concentrated on three severe, orphan, early-onset, treatment-resistant epilepsy syndromes – including Dravet syndrome, Lennox-Gastaut syndrome (LGS) and Tuberous Sclerosis Complex (TSC).
Pivotal-clinical trial program
- We have conducted a series of clinical trials designed to obtain safety and efficacy data on our cannabidiol oral solution to provide to the FDA and other regulatory authorities around the world, designed to support approval as a prescription medicine. Initial target indications include Dravet syndrome, Lennox-Gastaut syndrome, Tuberous Sclerosis Complex and Rett syndrome. In these trials, eligible patients are randomly assigned to receive GW's formulation of cannabidiol (Epidiolex) or placebo added to their current treatment and evaluated over a specific period of time. These trials are “blinded” meaning that patients, families, and physicians do not know which treatment arm they have been assigned.
- GW’s Phase 3 pivotal trial program for Epidiolex includes two Phase 3 trials in Dravet syndrome, two in LGS, and one in TSC. All of these trials have concluded. (see GW press releases: 14 March 2016, 27 June 2016, 26 September 2016 and 6 May 2019). Three of these studies are published in peer-reviewed journals to date – The New England Journal of Medicine and the Lancet.
- To learn more about GW’s ongoing Epidiolex clinical trials please see the ClinicalTrials.gov website here.
Support and Advocacy Organizations
There are a number of organizations which provide invaluable help, information, and support to people living with epilepsy. They are also a useful resource for caregivers, friends, and relatives. The following list includes links to some websites of patient organizations that may be useful.
Physicians, if you are interested in participating in a GW-sponsored clinical trial, please contact GW at: email@example.com