Advisory Committee recommends Nuplazid (pimavanserin) for the treatment of psychosis associated with Parkinson's disease- Acadia Pharma
Acadia Pharmaceuticals Inc. announced that the FDA Psychopharmacologic Drugs Advisory Committee (PDAC) voted 12 to 2 that the benefits of Nuplazid (pimavanserin) for the treatment of psychosis associated with Parkinson's disease outweigh the risks of treatment. The Prescription Drug User Fee Act (PDUFA) action date for completion of FDA review of the Nuplazid New Drug Application (NDA) is May 1, 2016.
The FDA has granted the NUPLAZID NDA Priority Review status and designated Nuplazid for the treatment of psychosis associated with Parkinson's disease as a Breakthrough Therapy.
Comment:The FDA decision was based on findings of a Lancet-published Phase III clinical trial, in which Nuplazid was associated with a -5.79 decrease in the Parkinson's disease-adapted scale for positive assessment of symptoms (SAPS-PD) versus -2.73 for placebo.
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