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 has developed an oral formulation of purified cannabidiol (CBD), approved as EPIDIOLEX® in the U.S. by the U.S. Food and Drug Administration (FDA) for seizures associated with Lennox-Gastaut syndrome or Dravet Syndrome, two rare and severe early-onset, drug-resistant epilepsy syndromes. This is the first cannabis plant-derived medicine ever approved by the FDA and it has been rescheduled by the U.S. DEA to a schedule V. The medicine was launched in the US as a prescription medicine by our US operating subsidiary, Greenwich Biosciences Inc., on November 1, 2018. This product has received approval in the EU by the European Medicines Agency (EMA) under the tradename EPIDYOLEX® for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients 2 years of age and older.*
GW successfully developed the world’s first prescription medicine derived from the cannabis plant, a complex botanical mixture called Sativex® (delta-9-tetrahydrocannibinol and cannabidiol) in Europe; nabiximols in the US, over ten years ago, which is now approved in over 25 countries outside of the US for the treatment of spasticity due to multiple sclerosis. GW continues to research and develop Sativex and is preparing to file and NDA in the United States by the end of 2019.
The company has a deep pipeline of additional clinical stage cannabinoid product candidates under development 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.
*See SmPC for full prescribing & safety information.