DUBLIN – Shares in GW Pharmaceuticals plc rose as much as 28 percent Monday on news that Epidiolex, its liquid formulation of plant-derived cannabidiol, hit the primary endpoint of a phase III trial in patients with Lennox-Gastaut syndrome (LGS), a rare and difficult-to-treat form of childhood-onset epilepsy. Following on from a positive read-out in March from a phase III trial in Dravet syndrome, another form of severe epilepsy, it’s further evidence that the drug has clinically significant anti-seizure effects, and it increases the company’s confidence of approval as it waits for a pre-NDA meeting date from the FDA.
London-based GW Pharma expects to file an NDA in both indications in the first half of 2017.
“These two positive trials provide a sizeable body of evidence supporting the efficacy and safety of Epidiolex in highly treatment-resistant forms of childhood-onset epilepsy,” GW CEO Justin Gover told analysts on conference call. “They