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GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) Report Publication Of Epidiolex® Trial In The Lancet

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GW Pharmaceuticals PLC- ADR

GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) reported that The Lancet has posted results from a Phase 3 trial of Epidiolex® in people with Lennox-Gastaut syndrome. Epidiolex, company’s lead product offering and the prospective first in a new segment of anti-epileptic drugs, is a pharmaceutical formulation of purified Hemp, a cannabinoid lacking elated side effects, which is being assessed for the treatment of several rare, grave pediatric-onset epilepsy ailments.

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In this study, Epidiolex considerably lowered monthly drop seizure frequency as against placebo in highly treatment-resistant people when added to current treatment. Treatment with Epidiolex was well tolerated, with a safety profile steady with previous reported experience. A NDA filing to the U.S. FDA for Epidiolex in the treatment of Dravet syndrome and LGS was accepted in last December with an intended PDUFA goal date of June 27, 2018 and, if permitted, the medicine is anticipated to be available in the United States by prescription in 2H2018.

A Marketing Authorization Application was filed to the European Medicines Agency in December 2017, with an anticipated decision next year. Justin Gover, the Chief Executive Officer of GW Pharmaceuticals, expressed that publication of this landmark trial by The Lancet is a thrilling achievement and records the second time that Epidiolex report has been published in an extremely renowned journal, following last year’s editorial in The New England Journal of Medicine.

These publications showcase the potential of Epidiolex to resolve the significant unmet need in Dravet syndrome and LGS, two very tough epilepsy conditions, and they look forward to associating with the EMA and FDA as they review their marketing applications for Epidiolex. They are absolutely focused on the objective of making this vital new drug available to appropriate people and their caregivers as fast as possible. The issue of this positive data is an exciting achievement for the LGS community.

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of MMJReporter.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure

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