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.
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.