Who Is GW?
GW Pharmaceuticals was founded in 1998, with operations in both the US and the UK. GW is dedicated to developing plant-derived cannabinoid therapeutics. Their lead product is Epidiolex. It is pure cannabidiol extract for rare, early-onset, drug-resistant severe forms of epilepsy. GW also developed the world’s first cannabis based prescription medicine, Sativex, intended for treatment of spasticity due to multiple sclerosis.
The company has a pipeline of clinical stage cannabinoid products focused on neurological conditions: Epidiolex for Tuberous Sclerosis, Lennox Gastaut Syndrome and Dravet Syndrome; CBDV (GWP42006) for Epilepsy and Autism Spectrum Disorders; GWP42003 (IV) for Neonatal Hypoxic-Ischemic Encephalopathy; GWP42002/ GWP42003 for Glioblastoma; and GWP42003 for Schizophrenia.
GW’s primary goal is to “maintain a world leading position in the field of cannabinoid science and in the research, development and commercialization of cannabinoid molecules as novel prescription pharmaceutical therapeutic candidates.” GW’s Chief Executive Officer, Justin Gover, defines the company’s values here in their mission statement.
Our primary purpose is to make a positive and meaningful difference in the lives of patients and their caregivers. All of our actions and decisions tie back to this most important and simple fact. Equally, we want our employees to understand and trust that GW Pharmaceuticals and its US subsidiary, Greenwich Biosciences, is committed to doing the right thing. So, we have made it clear what we expect from all of our colleagues.
What Is Epidiolex?
Epidiolex is is the lead cannabinoid based product from GW. It is made from pure CBD also known as cannabidiol and it is to be taken orally. The development of Epidiolex required it to go through two processes run by the government. They are the Food and Drug Administration (FDA) authorized clinical trials and the FDA authorized compassionate use and independent physician led programs.
The clinical trials are carried out to ensure that Epidiolex is safe and cable of producing the intended results GW wish to use it for. This will ensure for example that it could help people with epilepsy with zero major side effects and as few minor side effects as possible. These trials would also allow GW to understand what side effects they must warn patients of on their product when selling it as well. Once these trials are concluded Epidiolex could then be provided as a prescribed medication.
It may be of interest to know that when these trials are being carried out patients/participants are given Epidiolex or a placebo randomly and blindly. This allows the trials to be as fair as possible, and ensures no one is given special treatment (more serious patients get the drug). If you are worried some patients are not given any medication for their condition it would please you to know that during these trials the drug (Epidiolex) is only provided along side the patients/participants normal everyday medication to see if it improves their condition.
During phases 1 and 2 of the trials, Epidiolex was found to reduce seizures significantly in patients/participants compared to those that took the placebo. It it currently going through a third phase which will target Tuberous Sclerosis Complex (TSC), Lennox-Gastaut syndrome (LGS) and Dravet syndrome. All of which can be fatal for the patient.
Within a compassionate use program, the FDA may authorize expanded access to investigational drugs to treat patients with serious or immediately life-threatening diseases or conditions that lack medical alternatives. This is done through Investigational New Drug (IND) applications through the FDA.
The FDA has granted individual patient emergency IND’s to physicians and state programs to treat patients suffering from intractable (uncontrollable) epilepsy. Results from 261 IND’s have shown results of seizure reduction.
What Is Epidiolex For?
Epidiolex is primarily focused on types of epilepsy syndromes that begin at an early age, that can be fatal and that are resistant to other forms of treatment already available. These severe forms of epilepsy would include Tuberous Sclerosis Complex (TSC), Lennox-Gastaut syndrome (LGS) and Dravet syndrome.
Dravet syndrome is a genetic dysfunction of the brain. It is rare and begins in the first year of life. It is lifelong and causes most children to develop some type of developmental disability.
Lennox-Gastaut Syndrome is a type of epilepsy with multiple different types of seizures. A child’s intellectual development is usually impaired. In approximately a quarter of children, no cause can be confirmed. The patient’s seizures don’t normally respond to conventional medications. LGS accounts for only 2-5% of childhood epilepsies. LGS normally lasts through childhood, adolescence, to adulthood.
Tuberous Sclerosis Complex (TSC) is a genetic condition that results in tumors appearing on vital organs such as the lungs, eyes, heart, kidneys and brain. It can also appear on the skin. It impacts the central nervous system and results in certain symptoms, including seizures, kidney disease, skin abnormalities, behavioral problems and developmental delay.
Infantile Spasms, also known as west syndrome and as it clearly states, relate to spasms in very young children. In some cases they can begin while the child is in their first year of life (four to eight months) which makes it all the more traumatic for their family. These types of spasm regularly occur during feeding and after the child as woken up.