• GW Pharmaceuticals (GWPH) Phase 3 Results of Epidiolex for Dravet Syndrome and Lennox-Gastaut Syndrome

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    Biotech_Forecast
    Clinical and Regulatory
    Event Type: Phase 3 Results
    Timing: H2 2016
    Designation(s): Fast Track, Orphan Drug

    This event is set for a broad date range and therefore the exact timing is unknown. This adds a degree of risk.
    FDA special designations may increase the likelihood of success and decrease the time to approval.
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    Disease and Treatment
    Disease: Neurology
    Indication: Dravet Syndrome, Lennox-Gastaut Syndrome
    Lead Indication?: Yes
    Treatment Name: Epidiolex

    Likelihood of event success varies depending on disease, treatment and lead indication classification.
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    Company Information
    Co. Name: GW Pharmaceuticals
    Stock Symbol: GWPH
    Shares Traded: NASDAQ

    The OTC BB and OTC Markets have less stringent reporting and financial requirements than the NASDAQ and NYSE. This may increase the level of risk for investors. Smaller size may have an influence on likelihood of success.
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    Event Status
    Event Outcome: Positive
    Event Discussion: Forums
    Event Announcement(s): http://www.gwpharm.com/PR260916.aspx
    Partnership: No

    Partnerships help smaller biotech companies finance the long approval process. Partnership also provides validation the clinical program may be a worthy investment.
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    Detailed Event Description from Company Announcement

    Quote

    London, UK; 26 Sept 2016: GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: “GWP,” “GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces positive results of the second randomized, double-blind, placebo-controlled Phase 3 clinical trial of its investigational medicine Epidiolex® (cannabidiol or CBD) 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 percent compared with a reduction of 17 percent in patients taking placebo (p=0.0047), and patients taking Epidiolex 10mg/kg/day achieved a median reduction in monthly drop seizures of 37 percent compared with a reduction of 17 percent in patients taking placebo (p=0.0016).

     


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