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New Drugs for Parkinson Successfully Listed in US!
2017-03-23
来源：转载自第三方
23 March 2017
On 21 March, Xadago (safinamide), developed by Zambon and Newron Pharmaceuticals, was approved by the US Food and Drug Administration (FDA) as an addition to levodopa/carbidopa therapy. This is the first new chemical entity approved for the treatment of Parkinson's disease for more than a decade.
Parkinson's disease (PD) is a common neurological degeneration disease with an average age of about 60 years. It is the second most common chronic recurrent neurological degenerative disease in the world only after Alzheimer's disease. The most important pathological changes are the rapid functional degradation of "substantia nigra" parts in the brain, which can not produce a nerve conduction material "dopamine",making the restrictions for ability of the brain conducting muscle activity and greatly hinder the capacity for action of patients. Once "dead" substantia nigra cells are more than 50%~80%, the other areas in brain involved in movement control will be no longer able to work together, when the patient's movement will become messy and unable to control. The exact cause of this pathological change is still unclear, genetic factors, environmental factors, age, oxidative stress all may be involved in PD dopaminergic neuronal degeneration process. In short, Parkinson's disease may be the result of the interaction of multiple genes and environmental factors.
At present, levodopa is the most effective drug for the treatment of Parkinson's disease, however, long-term use of this drug may lead to severe fluctuations in exercise capacity: in the "on" period, the patient's athletic ability is normal; and in the "off" period, the patient's athletic ability will appear a significant decline. Thus, the patient needs additional drugs to cope with and manage the fluctuation of athletic ability due to taking levodopa. Xadago is a drug that responds to the "off" phase, a novel monoamine oxidase B (MAO-B) selective inhibitor that blocks neurons by voltage-dependent sodium channels to regulate the release of glutamate. The drug is recommended in combination with levodopa or other Parkinson drugs for advanced treatment of Parkinson's disease in middle and advanced stage.
The efficacy was also confirmed in clinical trials: Xadago can effectively control dyskinesia and motor disorders of Parkinson's patients in the short term, the effect can be maintained for 2 years. Compared with patients taking placebo, those who took Xadago had a significantly longer "on" period, and the "off" period was shortened. In addition, in the "on" period, the patient's athletic ability score is also higher, and no uncontrolled movement. Based on these data, FDA approved the listing of this drug.
From 24 February 2015, Xadago has been licensed to a number of European countries, including UK, Germany, Switzerland, Spain, Italy, Belgium, Denmark, Sweden and so on, it has brought more clinical treatment options for many European Parkinson's patients. But the drug did not go well in the United States, after the FDA had rejected the listing of the drug application, and asked to provide more information on the potential abuse of this drug. Now, the drug has been approved by FDA, which will bring greater market potential.
Parkinson was a relentless disease without a cure, even though James Parkinson wanted to be able to find drugs to stop the progress of Parkinson's disease since 1817. FDA approval of Xadago treatment for patients with Parkinson's disease is an important milestone, because it is the first new chemical entity approved for the treatment of Parkinson's disease by FDA nearly 10 years. We also hope that more new drugs can be listed to bring effective treatment for patients suffering from central nervous system diseases.
Edited by the Editorial Office of Suzhou Yacoo Science Co., Ltd.
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