Catalyst

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PDUFA date May 1 2016 of NUPLAZID (Pimavanserin) for Parkinson's disease psychosis (PDP) - under priority review

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Additional Relevant Details NUPLAZID is a new class of non-dopaminergic antipsychotic that acts as an SSIA (selective serotonin inverse agonist), preferentially targeting 5-HT2A receptors. Through this novel mechanism, NUPLAZID has demonstrated significant efficacy in Parkinson’s disease psychosis. According to the National Parkinson Foundation, about one million people in the United States and from four to six million people worldwide suffer from Parkinson’s disease. An estimated 40 percent of these patients have Parkinson’s disease psychosis, which is characterized by hallucinations and delusions, a diminished quality of life, and significant caregiver burden. ACADIA’s NDA submission is based on data from a comprehensive development program assessing the safety and efficacy of NUPLAZID for Parkinson’s disease psychosis. The NDA includes data from the pivotal Phase III -020 Study, in which NUPLAZID showed statistical improvement on all primary and secondary efficacy endpoints with no worsening of motor function. Detailed results of the -020 Study were published in The Lancet.
http://ir.acadia-pha...
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Catalyst Date
Occurred on:
Apr 29, 2016
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Related Keywords Pdufa, Pimavanserin, Parkinson's Disease Psychosis, Priority Review, Priority Review Designation