FDA approves GW's Epidiolex oral liquid to market
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Last Update: 2020-06-11
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Source: Internet
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Author: User
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Today, the U.Sfdaannounced the approval of thePharmaceutical," the company's, to marketEpidiolex is primarily used to treat two rare and severe types of epilepsy - Dravet syndrome and Lennox-Gastaut syndrome, which is also the first FDA-approvedof purified cannabisextract (
new drugAbout Epidiolex
Epidiolex is an oral, high-purity cannabidiol (CBD) extract liquid preparation, CBD is a non-psychotic ingredient from cannabis plants that has a variety of pharmacological effects on the nervous systemNumerous studies have shown that CBD has significant anti-epileptic and anticonvulsant activity, with fewer(side effects) than existing anti-epilepticdrugsstudiesEpidiolex's potential to treat epilepsy was in three randomized, double-blind, placebo-controlled clinical trials These clinical programs recruited 516 patients and showed that Epidiolex was used in combination with other drugs to effectively reduce the frequency of seizures compared to placebos previously, because of its therapeutic potential, Epidiolex has been awarded the FDA-issued fast-track qualification (for Dravet syndrome) and orphan drug eligibility (for both types of epilepsy) The FDA also granted it priority review eligibility after the listing application was accepted In addition, the FDA granted Epidiolex the status of an orphan drug for the treatment of rare hereditary nodule sclerosis (TSC) in 2016
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