GW To File In The USA After Results Of Study Published In New England Jnl of Medicine

The report goes on to reveal

GW first reported in March 2016 that Epidiolex cut monthly convulsive seizures by 39 percent in children with Dravet syndrome, but full results of the 120-patient study were only published in the New England Journal of Medicine  (Subscription access only) on Wednesday.

The journal article also showed that 5 percent of patients stopped having seizures altogether and 43 percent saw their seizures cut by half.

GW’s medicine, which is given as a syrup, is a purified form of cannabidiol, one of the active ingredients found in marijuana. It contains less than 0.1 percent of tetrahydrocannabinol, the substance that makes people high.

Stephen Wright, GW’s chief medical officer, said the company would submit its application to the Food and Drug Administration by mid-year, with a filing in Europe following a little later in 2017.

GW is seeking regulatory approval to sell Epidiolex as a treatment for both Dravet and Lennox-Gastaut syndrome, another severe form of epilepsy.

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