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    Home > Active Ingredient News > Drugs Articles > FDA approved the first new Parkinson's disease drug in ten years

    FDA approved the first new Parkinson's disease drug in ten years

    • Last Update: 2017-03-22
    • Source: Internet
    • Author: User
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    Source: yaomingkant 2017-03-22 today, great news comes from the field of central nervous disease treatment FDA announced that xadago (safinamide), a new Parkinson's disease drug developed by newron pharmaceuticals, has been approved for marketing as an additional therapy in addition to levodopa / carbidopa treatment It is also the first new chemical entity approved for Parkinson's disease treatment in the United States in more than a decade Parkinson's disease is the second most common chronic progressive neurodegenerative disease in the world, only inferior to Alzheimer's disease It is estimated that about 1-2% of the world's over-65-year-olds are affected by the disease With the global aging, the number of people suffering from the disease is likely to increase further At present, levodopa is the most effective drug in the treatment of Parkinson's disease The proportion of patients taking levodopa is as high as 75% However, long-term use of the drug may result in severely impaired motor ability fluctuations This fluctuation can be divided into two stages: in the "on" stage, the patient's motor ability is all normal; in the "off" stage, the patient's motor ability will decline significantly, even walking is difficult Therefore, with the development of the disease, these patients need additional drugs to deal with and manage the fluctuation of exercise ability caused by taking levodopa Safinamide, approved today, is a drug that can cope with the "off" phase and selectively inhibit mao-b As a monoamine oxidase, MAO-B can degrade dopamine, and dopamine can transmit signals in brain area, which is very important for smooth autonomous movement Therefore, safinamide is expected to avoid the degradation of dopamine by mao-b Through this mechanism, the researchers hope that safinamide can alleviate the decline of motor ability of patients with Parkinson 's disease in the "off" period In two clinical trials involving 645 and 549 Parkinson's patients, the efficacy of safinamide was confirmed Compared with patients taking placebo, those taking safinamide had significantly longer "on" period and shorter "off" period In addition, in the "on" phase, patients' motor ability scores were higher, and there was no uncontrolled movement Based on these data, the FDA approved the drug's launch today "FDA approval of xadago for Parkinson's disease is an important milestone because it is the first new chemical entity approved for Parkinson's disease treatment in the United States in more than a decade," said Warren, emeritus professor, Mount Sinai Medical School Dr olanow said: "in addition to levodopa / carbidopa, xadago as an additional therapy can significantly reduce the time of 'off' phase and significantly increase the time of 'on' phase In the 'on' phase, it also does not cause dyskinesia " "Parkinson's is a relentless disease, there is no cure," said Dr Eric bastings, deputy director of neurological products at the FDA Center for drug evaluation and research "We are committed to bringing more Parkinson's treatments to patients." We congratulate newron pharmaceuticals and its partners on their achievements, and we wish more new drugs to be launched to treat patients with central nervous system diseases Reference: [1] FDA approvals xadago ® (safeamide) for Parkinson's disease (PD) patients [2] FDA approvals drug to treat Parkinson's disease [3] after an odyssey of setbacks, FDA finally green lights newron's Parkinson's drug xadago
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