FDA accepts new drug application for opicapone
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Last Update: 2020-06-09
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Source: Internet
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Author: User
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FDA(http://has acceptednew drug(http://application (NDA), Neurocrine Biosciences announcedOpicapone is a new, daily, oral selective catechol-O-methyl transferase (COMT) inhibitor as an adjuca-assisted therapy for people with Parkinson's disease who are experiencing movement fluctuations (OFF events)The FDA has set a target date for the NDA's Prescription Drug User Charge (PDUFA) date of April 26, 2020If approved, opicapone will offer a new treatment to extend the efficacy of LevodopaOpicapone NDA is supported by data from 38 clinical studies, including 2 Phase III clinical studies BIPARK-1 and BIPARK-2, and more than 1,000 patients with Parkinson's disease received opicapone treatmentData from two Phase III studies showed that within two hours of taking the drug, opicapone significantly reduced the patient's involuntary exercise time and "switching" In the European Union, based on the above two Phase III studies, opicapone was approved in June 2016 as an auxiliary therapy for l-doba/doba acetase inhibitors (DDCI, such as carbideba) for adult patients with Parkinson's disease who received these combination therapies that do not stabilize endomottic movement The drug is currently available in Germany, the UK, Spain, Portugal and Italy under the brand name Ongentys
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