Application for registration of a drug based on cannabidiol will be filed this year

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GW Pharmaceuticals intends to send a package of documents to the US Food and Drug Administration (FDA) this year for the registration of a drug based on cannabidiol, intended for the treatment of severe forms of epilepsy in children. It is reported Reuters.
In 2016, GW Pharmaceuticals presented the results of studies, according to which the use of Epidiolex (39%) reduces the number of epileptic seizures in children with the Drave syndrome.In another study, it was shown that the use of the experimental drug among patients with Lennox-Gastaut syndrome for 14 weeks contributed to a 44% reduction in the seizure frequency, whereas in the placebo group, this was 22%. The preparation is presented in the form of a syrup and contains less than 0.1% tetrahydrocannabinol.
According to the company's plans, the drug will be registered immediately on two indications - for the treatment of Drave and Lennox-Gastaut syndromes. According to forecasts of market analysts, annual sales of Epidiolex can reach $ 1.6 billion in 2023.

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