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 in patients 2 years of age and older, two rare and severe early-onset, drug-resistant epilepsy syndromes and is now under regulatory review for seizures associated with Tuberous Sclerosis Complex or TSC. This is the first cannabis plant-derived medicine ever approved by the FDA and has been descheduled by the U.S. DEA. 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 called Sativex® (nabiximols) in Europe, a formulated cannabis extract that contains the principal cannabinoids delta-9-tetrahydrocannibinol (THC) and cannabidiol (CBD), as well as other minor cannabinoids and terpenes, which is now approved in numerous countries outside of the US for the treatment of spasticity due to multiple sclerosis. GW continues to research and develop nabiximols and is commencing separate clinical programs in the United States for spasticity due to multiple sclerosis and spinal cord injury.
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.
*See SmPC for full prescribing & safety information.