{"id":25296,"date":"2014-09-02T18:12:49","date_gmt":"2014-09-02T22:12:49","guid":{"rendered":"http:\/\/sciencebusiness.technewslit.com\/?p=25296"},"modified":"2016-06-11T12:45:36","modified_gmt":"2016-06-11T16:45:36","slug":"breakthrough-status-given-parkinsons-psychosis-drug","status":"publish","type":"post","link":"https:\/\/technewslit.com\/sciencebusiness\/?p=25296","title":{"rendered":"Breakthrough Status Given Parkinson’s Psychosis Drug"},"content":{"rendered":"
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2 September 2014. Acadia Pharmaceuticals<\/a> says the U.S. Food and Drug Administration designated its drug candidate pimavanserin as a breakthrough therapy for the treatment of psychosis associated with Parkinson’s disease. Acadia is a biopharmaceutical company in San Diego specializing in neurological and central nervous system disorders.<\/p>\n

Pimavanserin<\/a> is Acadia’s lead therapy candidate, to be offered under the trade name Nuplazid, and designed for patients with Parkinson’s disease experiencing periods of psychosis. Parkinson’s disease<\/a> is probably best known for its physical symptoms like tremors and balance problems, but the disorder can also lead to psychiatric symptoms including hallucinations and delusions.<\/p>\n

The company cites data indicating up to 40 percent<\/a> of Parkinson’s disease patients have occurrences of psychosis, with no treatment yet approved for the condition in the U.S. Patients with psychosis as well as the physical symptoms experience a sharply reduced quality of life and impose a significant burden on caregivers.<\/p>\n

Pimavanserin is a small molecule drug that binds to receptor proteins in the brain associated with psychosis, and exert a controlling or moderating influence on those receptors. The drug is administered orally once a day. In October 2013, Acadia reported results of a late-stage clinical trial<\/a> in the journal The Lancet<\/em><\/a> showing Parkinson’s disease patients taking pimavanserin have fewer experiences of psychosis, such as hallucinations and delusions, while maintaining motor control, compared to a placebo.<\/p>\n

FDA designates therapy candidates as breakthroughs<\/a> when they address a serious condition and demonstrate through clinical evidence that the treatment is a substantial improvement over current methods. Once designated as a breakthrough therapy, a drug or biologic can receive early and frequent communications with FDA staff, quick resolution of questions, intensive guidance on drug development, and an organizational commitment from top managers at FDA.<\/p>\n

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