GW has established a world leading position in the development of plant-derived cannabinoid therapeutics through its proven drug discovery and development processes, intellectual property portfolio and regulatory and manufacturing expertise.
GW is developing an oral formulation of purified cannabidiol (CBD) which has been approved by the US Food and Drug Administration for two rare and severe early-onset, drug-resistant epilepsy syndromes.
GW successfully developed the world’s first prescription medicine derived from the cannabis plant, which is now approved in over 25 countries outside of the US for the treatment of spasticity due to multiple sclerosis.
The company has a deep pipeline of additional clinical stage cannabinoid product candidates for both orphan and non-orphan indications with a particular focus on neurological conditions.
GW Pharmaceuticals was founded in 1998 and is listed on the NASDAQ Global Market (GWPH). The company has operations in both the US and the UK.
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.
GW cannabinoid research is initially concentrating on severe, orphan, early-onset, treatment-resistant epilepsy syndromes including Dravet syndrome, Lennox-Gastaut syndrome (LGS) and Tuberous Sclerosis Complex (TSC).
GW’s Cannabinoid development includes two distinct programs:
FDA-authorized clinical trials program
- We have conducted a series of clinical trials designed to obtain safety and efficacy data on CBD to provide to the FDA and other regulatory authorities around the world, designed to support approval of marketing authorisation. Initial areas of particular interest include Dravet syndrome, Lennox-Gastaut syndrome and Tuberous Sclerosis Complex. In these trials, eligible patients are randomly assigned to receive GW’s oral 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 current Phase 3 pivotal trials program 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 showed significantly greater reductions in specific seizure types for patients taking GW CBD compared to those taking placebo. (see GW press releases: 14 March 2016 & 27 June 2016, 26 September 2016).
- To learn more about GW’s CBD clinical trials please see the ClinicalTrials.gov website here
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.
Physicians, if you are interested in participating in a GW-sponsored clinical trial, please contact GW at: email@example.com