Symptoms of PD psychosis can get worse over time1,2
- Hallucinations with insight can progress to hallucinations without insight and delusions
- Because patients commonly do not disclose their nonmotor symptoms, screening early for hallucinations and delusions may help identify psychosis earlier
NUPLAZID significantly reduced the frequency and/or severity of hallucinations and delusions associated with PD psychosis without impacting motor function3,4
- Primary efficacy was evaluated based on change from baseline to Week 6 in SAPS-PD total score (n=95 NUPLAZID; n=90)
- A key secondary endpoint was motor function change from baseline to Week 6 in UPDRS Parts II+III
SAPS-PD=Scale for the Assessment of Positive Symptoms adapted for Parkinson’s disease; UPDRS Parts II+III=Unified Parkinson’s Disease Rating Scale Parts II and III
NUPLAZID has a demonstrated safety profile in patients with PD psychosis3,5
- The common adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%)
- Selected nonmotor adverse reactions included sedation-related events (6.4% NUPLAZID vs 5.2% placebo) and orthostatic hypotension–related events (6.9% NUPLAZID vs 10.4% placebo)
- Sedation-related events included sedation, somnolence, fatigue, asthenia, lethargy, and hypersomnia
- Orthostatic hypotension–related events included dizziness, hypotension, orthostatic hypotension, orthostatic intolerance, syncope, vertigo positional, postural orthostatic tachycardia syndrome, and vertigo
Important Safety Information
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis.
Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported.
Warnings and Precautions: QT Interval Prolongation
NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics.
NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.
Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mg taken orally as one tablet once daily.
Coadministration with strong or moderate CYP3A4 inducers reduces NUPLAZID exposure. Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID.