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On April 7, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that a 5.
Screenshot source: CDE official website
Parkinson's disease is a common neurodegenerative disease in middle-aged and elderly people
Publicly available data reveal that safinamide is a novel chemical entity with a unique mode of action involving selective and reversible monoamine oxidase B (MAO-B) inhibition and blockade of voltage-dependent sodium channels, thereby modulating aberrant glutamate acid release
According to public information, safinamide was developed by Newron Pharmaceuticals and commercialized by Zambon, Meiji Seika, Eisai, Supernus Pharmaceuticals and other companies
According to an earlier FDA press release, the efficacy of safinamide was demonstrated in two clinical trials involving 645 and 549 Parkinson's disease patients, respectively
According to the information on the China Drug Clinical Trial Registration and Information Publicity Platform, the China Phase 3 clinical study of safinamide as an adjuvant therapy for idiopathic Parkinson's disease has been completed
The submission of a listing application for safinamide tablets in China means that it will soon come to China, thereby benefiting more Parkinson's disease patients!
References:
[1] The official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China.
