GW Pharmaceuticals is closing in on a US filing for its cannabinoid epilepsy drug, Epidiolex, after trumpeting late-stage study findings.
The company specialises in drugs derived from the cannabis plant, and noted that the New England Journal of Medicine had published results from its phase 3 study of Epidiolex (cannabidiol) in the rare childhood epilepsy, Dravet Syndrome.
It says it is on track for a filing with the FDA in the coming months.
The latest results were based on a trial of 120 children aged two to 18 years, with Dravet syndrome seizures not controlled by other anti-epileptic regimens.
Results showed 5% of children became seizure free over the 14-week treatment period when treated with Epidiolex, an effect that did not occur in any of the patients on the placebo arm.
Overall patients in the treatment arm had a significantly greater median reduction in convulsive seizures (39%) compared with placebo (13%).
The proportion of patients who had
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