INFORMATION INTENDED FOR GLOBAL HEALTHCARE PROFESSIONALS

Cannabidiol oral solution

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 two severe, orphan, early-onset, treatment-resistant epilepsy syndromes – including Dravet syndrome, Lennox-Gastaut syndrome (LGS) – and is in Phase 3 trials for Tuberous Sclerosis Complex (TSC).

GW’s Epidiolex development includes two distinct programs:

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 and Tuberous Sclerosis Complex. In these trials, eligible patients are randomly assigned to receive CBD 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. Three of these trials, one in Dravet syndrome and two in LGS, have concluded. (see GW press releases: 14 March 2016 & 27 June 201626 September 2016).These three studies are published in peer-reviewed journals – 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.

Independent Physician-led programs, Expanded Access, or Compassionate Use Programs, for which GW supplies CBD* (click here for information on the U.S. Expanded Access Program)

  • The most recent physician-reported data from the FDA authorized Expanded Access Program was presented in December 2017 at the American Epilepsy Society’s annual meeting (Bebin et al). Results from 607 patients receiving Epidiolex under these INDs showed promising signals of clinical effect in reducing seizures (link to press release and poster).

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: medicalinformation@gwpharm.com