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GW Pharmaceuticals stock flies 4.8% after reporting positive test trial

Mon, 26th Nov 2018 15:49

(Sharecast News) - GW Pharmaceuticals stock rose by 4.8% on Monday after it announced positive test results from new cannabis-based drug trials.GW Pharmaceuticals announced positive top-line results on the second randomized, double-blind, placebo-controlled Phase 3 clinical trial of EPIDIOLEX, a new cannabis-based drug aimed at treating seizures associated with a rare and severe form of childhood-onset epilepsy.The trial achieved the primary endpoint of a reduction in convulsive seizures for the two dose levels (10 mg/kg per day and 20 mg/kg per day) with a high statistical significance compared to placebo."The positive outcome in this second trial of EPIDIOLEX in patients with Dravet syndrome further reinforces the effectiveness of this newly available medicine in this particularly difficult to treat, childhood-onset epilepsy," stated Ian Miller, M.D. the principal investigator of the trial. "The totality of data from the controlled clinical trials completed for EPIDIOLEX have shown clinically meaningful seizure reductions and a consistent safety and tolerability profile. I am excited that this recently approved and important new treatment option is now available for my patients," the company said in a statement.EPIDIOLEX is the first prescription, plant-derived cannabinoid medicine in the United States and the first in a new class of anti-epileptic medications. It is a pharmaceutical formulation of highly purified cannabidiol (CBD) now FDA approved for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older.GW submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for EPIDIOLEX with an expected decision in the first quarter of 2019.

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