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Cannabis Derived Product Received Third Orphan Drug Designation

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The British biopharmaceutical company, GW Pharmaceuticals received third Orphan Drug Designation from US Food and Drug Association (FDA) for Epidiolex®cannabidiol (CBD) to treat Tuberous Sclerosis Complex (TSC) condition. The company has showcased itself as a specialist of making novel therapeutics from its proprietary cannabinoid product platform for the treatment of rare forms of epilepsy.

GW Pharma UK logoGW Pharmaceuticals’ lead cannabinoid candidate, Epidiolex® (CBD) is a liquid formulation of pure plant-derived CBD which is in development for the treatment of rare epilepsy disorders in children. Epidiolex® has already received two Orphan Drug Designation from FDA and is in Phase III pivotal trials for treatment of two unique childhood-onset forms of epilepsy-Dravet’s syndrome and Lennox-Gastaut syndrome. GW Pharmaceuticals declared the inception of a 16 weeks long Phase III clinical trial of Epidiolex® as a treatment for the seizures associated with TSC whose promising results could catapult it in the US market.

TSC is a rare, genetic disorder that forms non-malignant tumors in various organs like brain, heart, eyes, skin etc. Its symptoms include seizures, developmental delay, behavioral abnormalities and various lung and kidney disease. About 80 to 90% of children with TSC develop epilepsy with the onset of seizures early in their childhood which leads to large number of morbidity and mortality.

GW Pharmaceuticals’ Epidiolex® received its third Orphan Drug Designation for this another catastrophic form of epilepsy- Tuberous Sclerosis Complex. Epidiolex® has really showed its worth as a potential treatment for severe forms of epilepsy.

GW Pharma cannabinoid pipeline

Figure 1. GW Pharma Cannabinoid product pipeline (Photo credit: GW Pharma website)

Last month we presented the promising Phase III results of Epidiolex® for Dravet syndrome. After the commercialization of the world’s first plant-derived cannabinoid drug, Sativex® for treatment of spasticity due to multiple sclerosis, GW  Pharmaceuticals have focused in evaluating the potential of cannabinoid product candidates for the treatment of various rare conditions. Now Epidiolex® Orphan Drug Designation from FDA for three rare and disastrous forms of epilepsy has really pushed GW Pharmaceuticals further to discover and develop its proprietary cannabinoid product platform for wide domain of disease areas.

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