FAQs

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Q & A
Who is Greenwich Biosciences Inc.?

Greenwich Biosciences was established in 2013 as the US subsidiary of GW Pharmaceuticals plc. 

We are advancing an orphan drug program in the field of epilepsy with a focus on Epidiolex® (cannabidiol), which is in Phase 3 clinical development for the treatment of Dravet syndrome, Lennox-Gastaut syndrome, Tuberous Sclerosis Complex and expects to commence a Phase 3 program in Infantile Spasms.

What are cannabinoids?

The cannabis plant is the unique source of more than 100 structurally-related, plant-derived cannabinoids. One cannabinoid, THC, is known to cause psychoactive effects associated with the use of illicit herbal cannabis. In recent decades, there have been major scientific advances that have led to the discovery of new plant-derived cannabinoids and a cannabinoid receptor system in the human body, or endocannabinoidsystem.

What is epilepsy?

Epilepsy is a neurological disorder characterized by at least two unprovoked seizures occurring in close proximity or by one unprovoked seizure with a high probability of further seizures.1

Reference:

  1. Fisher R et al. A practical clinical definition of epilepsy. Epilepsia. 2014 55(4):475-482
What is Dravet Syndrome?

Dravet syndrome is a rare genetic epileptic encephalopathy (dysfunction of the brain). It begins in the first year of life in an otherwise healthy infant. Prior to 1989, this syndrome was known as epilepsy with polymorphic seizures, polymorphic epilepsy in infancy (PMEI) or severe myoclonic epilepsy in infancy (SMEI).

 

Reference:

  1. Dravet C. The core Dravet syndrome phenotype. Epilepsia. 2011;52(suppl 2):3-9.
  2. Guerrini R, Falchi M. Dravet syndrome and SCN1A gene mutation related-epilepsies: cognitive impairment and its determinants. Dev Med Child Neurol. 2011;53(suppl 2):11-15.
  3. Catterall WA, Kalume F, Oakley JC. NaV1.1 channels and epilepsy. J Physiol. 2010;588(pt 11):1849-1859.
  4. Akiyama M, Kobayashi K, Ohtsuka Y. Dravet syndrome: a genetic epileptic disorder. Acta Med Okayama. 2012;66(5):369-376.
What is Lennox-Gastaut Syndrome (LGS)?

Lennox-Gastaut syndrome (LGS) is a type of epilepsy with multiple seizure types and characteristic slow spike wave EEG (during childhood). Intellectual development is usually, but not always, impaired. It is one of the more severe forms of epilepsy and is typically accompanied by developmental delay. Seizures are generally difficult to control due to their resistance to anti-epileptic drugs.

 

References:

  1. Lennox WG, Davis JP. Clinical correlates of the fast and the slow spike-wave electroencephalogram. Pediatrics. 1950;5(4):626-644.
  2. Gastaut H, Roger J, Soulayrol R, et al. Childhood epileptic encephalopathy with diffuse slow spike-waves (otherwise known as "petit mal variant") or Lennox syndrome. Epilepsia. 1966;7(2):139-179.
  3. French JA, Kanner AM, Bautista J, et al.; Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology; Quality Standards Subcommittee of the American Academy of Neurology; American Epilepsy Society. Efficacy and tolerability of the new antiepileptic drugs II: treatment of refractory epilepsy: report of the Therapeutics and Technology Assessment Subcommittee and Quality Standards Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology. 2004;62(8):1261-1273.
  4. Niedermeyer E. The Lennox-Gastaut syndrome: a severe type of childhood epilepsy. Dtsch Z Nervenheilkd. 1969;195(4):263-282.
  5. Bourgeois BF, Douglass LM, Sankar R. Lennox-Gastaut syndrome: a consensus approach to differential diagnosis. Epilepsia. 2014;55(suppl 4):4-9.
What is Tuberous Sclerosis Complex (TSC)?

Tuberous Sclerosis Complex is a rare multisystem genetic disease that causes tumors to grow in the brain and on other vital organs such as the kidneys, heart, eyes, lungs, and skin. Over 85% of patients with TSC have seizures.Common seizure types include infantile spasms, focal, tonic, tonic-clonic, atypical absence, and myoclonic.

 

Reference:

  1. Chu-Shore CJ, Major P, Camposano S, Muzykewicz D, Thiele EA. The natural history of epilepsy in tuberous sclerosis complex. Epilepsia. 2010;51(7):1236-1241
  2. Goh S, Kwiatkowski DJ, Dorer DJ, et al. Infantile spasms and intellectual outcomes in children with tuberous sclerosis complex. Neurology.2005;65:235-238
  3. Theile EA, Granata T, Matricardi S, Chugani HT. Transition into adulthood: tuberous sclerosis complex, Sturge Weber Syndrom and Rasmussen encephalitis. Epilepsia. 2014;55(suppl.3):29-33.
What are Infantile Spasms (IS)?

Infantile spasms, also known as West syndrome, are the most common epileptic encephalopathy in the first 2 years of life. IS generally consists of short, involuntary spasms, abnormal EEG (hypsarrhythmia), and developmental arrest or delay.1 

 

Reference:

  1. Taghdiri MM, Nemati H. Infantile Spasms: a review article. Iran J Child Neurology. 2014 Summer;8(3):1-5 
  2. Wirrell E et al. How Should Children with West Syndrome be Sufficiently and Accurately Investigated? Results of the National Infantile Spasm Consortium. Epilepsia 2014 April;56(4):617-625

Epidiolex (CBD) is an investigational drug not approved for any indication.