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Gocovri™ was approved by FDA for the treatment of Dyskinesia in Parkinson's Disease
2017-08-28
来源：转载自第三方
2017-8-28
Recently, Adamas Pharmaceuticals announced in its official website, that Gocovri (amantadine) extended release capsules (previously ADS-5102) for treatment of dyskinesia in patients with Parkinson's disease has been approved by FDA. It is the first and only medicine approved by the FDA for this indication.
Parkinson's disease is a chronic neurodegenerative disease that can last for decades. As the disease progresses, the clinical symptoms are complex and can not be cured. Parkinson's disease is caused by the loss of dopamine in the brain, so patients usually need to use levodopa treatment to slow the development of the disease. Levodopa is currently the most effective drug for the treatment of Parkinson's disease, as high as 75% patients are taking the drug. However, long-term use of levodopa can lead to severe debilitating exercise capacity fluctuations, usually manifested as slow movement, stiffness, walking disorders, tremors and posture instability. According to the statistics, about 90% of patients with levodopa will develop dyskinesia, manifested as involuntary, rhythmic movement, and which is unpredictable and greatly affecting the patient's daily life.
Adamas Pharmaceuticals is committed to developing new drugs for the treatment of chronic nervous system diseases. Gocovri is a daily oral drug containing high doses of amantadine for the treatment of movement disorders that occur during the day. The approval of Gocovri was based on data from two Phase 3 clinical trials: in the first trial, patients experienced significant dyscinesia decreasing during the 12-week treatment, and the UDysRS score decreased 37%, while the placebo group decreased by only 12%; the second study further confirmed the results, Gocovri achieved UDysRS decreased by 46%, while the placebo group was 16%.
Gocovri's approval resolves the embarrassing situation in which there is no drug for dyskinesia of Parkinson's disease. Adamas Pharmaceuticals also plans to extend Gocovri's indications to other chronic neurological disorders such as multiple sclerosis walking disorders, post-stroke walking disorders, and several others Indications.
The drug is predicted to be available in the fourth quarter of this year and will begin overall sales in January next year. The approval of this new drug provides effective treatment for Parkinson's patients who suffer from dyskinesia. We also hope that more new drugs can be listed, thus delaying the progress of the disease, and effectively improving the quality of life of patients.
Edited by Suzhou Yacoo Science Co., Ltd.
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