GW has been researching cannabinoids since 1998 and has established a world leading position in the development of plant-derived cannabinoid therapeutics through our proven drug discovery and development processes, our intellectual property portfolio and our regulatory and manufacturing expertise. GW’s research explores the potential therapeutic application of cannabinoids and we have evaluated the pharmacology of a number of cannabinoids across a wide range of disease areas.
Our primary focus is on disorders of the central nervous system (CNS), including certain forms of epilepsy. Our lead cannabinoid product is a liquid formulation of highly purified plant-derived cannabidiol, or CBD. In the United States, this product is called EPIDIOLEX® and is FDA approved for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients 2 years of age and older, two rare and particularly difficult to treat forms of epilepsy and is now under regulatory review for seizures associated with Tuberous Sclerosis Complex or TSC. The product was launched in November 2018 and is now available by prescriptions in the U.S. In Europe and the UK, this product is named EPIDYOLEX® and has received approval in the EU by the European Medicines Agency (EMA) 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. We have launched Epidyolex in Germany and the U.K. and are planning launches in France, Italy and Spain during 2020.
We commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex® (nabiximols), which is approved for the treatment of spasticity due to multiple sclerosis in numerous countries outside the United States. GW is now commencing a pivotal clinical program with the goal of an NDA submission for nabiximols in the U.S for the treatment of spasticity due to multiple sclerosis and spasticity due to spinal cord injury.
We have a deep pipeline of additional cannabinoid product candidates which include compounds in development for autism spectrum disorder, NHIE and schizophrenia.
GW is in a unique position to develop and manufacture plant-derived cannabinoid formulations worldwide at sufficient quality, uniformity and scale for the purposes of pharmaceutical development and to meet international regulatory requirements.
Cannabidiol (CBD) Oral Solution
Approved as Epidiolex® in the United States
For US HCPs seeking information about our US subsidiary, Greenwich Biosciences, Inc., Click here
Sativex is a cannabinoid medicine for the treatment of multiple sclerosis spasticity.