GW Pharmaceuticals Plc.OTCPK - Current
Mon, Sep. 26, 7:45 AM
- GW Pharmaceuticals (NASDAQ:GWPH) announces positive results of the second randomized, double-blind, placebo-controlled Phase 3 clinical trial of its investigational medicine Epidiolex (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy.
- In this trial, Epidiolex, when added to the patient’s current treatment, achieved the primary endpoint for both dose levels with high statistical significance. During the treatment period, patients taking Epidiolex 20mg/kg/day achieved a median reduction in monthly drop seizures of 42% compared with a reduction of 17% for placebo, and patients taking Epidiolex 10mg/kg/day achieved a median reduction in monthly drop seizures of 37% compared with a reduction of 17% for control.
- This trial follows the announcement in June of positive results in the first pivotal Phase 3 trial of Epidiolex for the treatment of seizures associated with LGS, and the March announcement of positive results in the treatment of seizures associated with Dravet syndrome. GW expects to submit a New Drug Application (NDA) to the FDA in H1 2017.
- Shares are up 13% premarket on increased volume.
Wed, Feb. 10, 7:07 AM
- GW Pharmaceuticals (NASDAQ:GWPH): FQ1 Net Loss of £17.7M
- Revenue of £3.7M (-53.8% Y/Y)