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GW Pharma’s cannabis-based epilepsy drug granted orphan designation by FDA

Published on 21/04/16 at 02:27pm

GW Pharmaceuticals (NASDAQ: GWPH) has announced that the US Food and Drug Administration has granted its cannabis-based epilepsy drug, Epidiolex (cannabidiol), orphan drug designation.

This latest positive step in GW’s development of Epidiolex follows positive Phase III trial results which saw shares more than double.

Epidiolex is intended for the treatment of tuberous sclerosis complex (TSC), a rare genetic disorder of which a common symptom is epilepsy. The drug is currently in development for the treatment of a number or rare paediatric epilepsy disorders and remains in Phase III trials for TSC, as well as Dravet syndrome and Lennox-Gastaut syndrome, which are both rare forms of childhood-onset epilepsy.

Commenting on the Phase III TSC trials for epidiolex, chief executive of GW, Justin Glover, says: “Our decision to evaluate Epidiolex in TSC is based on findings from the physician-led Epidiolex expanded access program, which found that TSC patients reported reductions in seizure activity. With the commencement of this trial, GW’s Epidiolex development program now encompasses three rare epilepsy indications with pivotal trials fully underway.”

Sean Murray

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