GW Pharmaceuticals plc GWPH announced that data on its cannabidiol-based drug, Epidiolex, from the physician-led expanded access program in treatment-resistant epilepsy were published in The Lancet Neurology.
As per the published paper, Epidiolex reduced seizure frequency across multiple drug-resistant epilepsy syndromes and seizure types, and administration of Epidiolex as an add-on treatment led to a clinically meaningful reduction in seizure frequency in many patients. The candidate was generally well tolerated and demonstrated an adequate safety profile in this patient population with high treatment-resistant epilepsies. However, authors noted that results regarding efficacy and safety should be interpreted cautiously given the lack of a control group.
Epidiolex is currently in phase III development for the treatment of Dravet syndrome and Lennox-Gastaut syndrome. The phase III pivotal safety and efficacy studies in Dravet syndrome and Lennox-Gastaut Syndrome are currently near completion. These will provide the placebo-controlled efficacy and safety profile. Data from these studies are expected to mature in 2016.
The company plans to initiate another phase III study on Epidiolex for the treatment of tuberous sclerosis complex in the first quarter of 2016. Epidiolex has Fast Track designation in the U.S. for the treatment of Dravet syndrome, which should expedite the review process. Epidiolex also enjoys Orphan Drug designation in the U.S. for the treatment of Dravet syndrome and Lennox-Gastaut syndrome. Investor focus is expected to remain on pipeline updates.
GW Pharma holds a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Achillion Pharmaceuticals, Inc. ACHN, Horizon Pharma plc HZNP and Corcept Therapeutics Incorporated CORT. All the three stocks sport a Zacks Rank #1 (Strong Buy).
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