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Breakthrough Status Given Parkinson’s Psychosis Drug

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2 September 2014. Acadia Pharmaceuticals 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.

Pimavanserin 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 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.

The company cites data indicating up to 40 percent 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.

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 in the journal The Lancet 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.

FDA designates therapy candidates as breakthroughs 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.

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