GW’s Epidiolex® 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.
Epidiolex is GW’s lead cannabinoid product candidate and is a proprietary oral solution of pure plant-derived cannabidiol, or CBD. GW’s Epidiolex development is initially concentrating on severe, orphan, early-onset, treatment-resistant epilepsy syndromes including Dravet syndrome, Lennox-Gastaut syndrome (LGS), Tuberous Sclerosis Complex (TSC) and Infantile Spasms (IS).
GW’s Epidiolex development includes two distinct programs:
FDA-authorized clinical trials program
- We have commenced a series of clinical trials designed to obtain safety and efficacy data on Epidiolex to provide to the FDA and other regulatory authorities around the world, which is necessary to be considered for approval as a prescription medicine. Target indications currently include Dravet syndrome, Lennox-Gastaut syndrome, Tuberous Sclerosis Complex, and Infantile Spasms. In these trials, eligible patients are randomly assigned to receive 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 current Phase 3 pivotal trials program for Epidiolex includes two Phase 3 trials in Dravet syndrome, two in LGS, one in TSC, and one in IS. The first two of these Phase 3 trials, one in Dravet syndrome and one in LGS, have showed significantly greater reductions in specific seizure types for patients taking Epidiolex compared to those taking placebo. (see GW press releases: 14 March 2016 & 27 June 2016, 26 September 2016).
- To learn more about GW’s Epidiolex clinical trials please see the ClinicalTrials.gov website here.
- Link to a form for your health care professional to fill out to reach GW’s medical affairs group. Please note: You must be a health care professional (HCP) to fill out this form. By clicking submit, you are confirming you are a health care professional. Please do not include any patient-identifying information.
FDA-authorized, independent Physician-led program or Expanded Access (which are at times called Compassionate Use programs in some countries) and for which GW supplies Epidiolex* (click here for information on the U.S. Expanded Access Program)
- The FDA may authorize expanded access programs to facilitate access to investigational drugs for treatment use for patients with a serious or immediately life-threatening disease or condition who lack therapeutic alternatives. This is done through FDA granting Investigational New Drug (IND) applications.
- The FDA has granted individual patient emergency INDs to physicians as well as INDs to physicians and state programs to treat groups of patients suffering from intractable epilepsy with Epidiolex.
- The most recent physician-reported data from this Expanded Access Program was presented in December 2015 at the American Epilepsy Society’s annual meeting. Results from 261 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.
GW is committed to respecting the primary role of healthcare providers in the treatment of epilepsy disorders. Therefore, we cannot respond to medical questions about your personal health situation, nor can we accept private medical information. Please contact your healthcare provider with any questions pertaining to your or a family member's medical condition
If you are interested in participating in a GW-sponsored clinical trial, please have your physician contact GW at: email@example.com