Start patients on NUPLAZID® (pimavanserin) 34 mg—the only FDA-approved therapy proven to reduce delusions and hallucinations associated with PD psychosis in elderly patients.1,2
(Not actual size)
ONE FDA-approved treatment, ONE small* capsule, ONE daily dose
- Reduces the frequency and/or severity of PD psychosis–related delusions and hallucinations without impacting motor function
- Demonstrated safety profile in elderly patients† with PD psychosis
- In vitro, a serotonergic agent with no appreciable affinity for D2, histamine, muscarinic, or adrenergic receptors‡
*Actual size is 14.3 mm X 5.3 mm.
†The maximum age in the clinical studies was 90 years old.3
‡The precise mechanism of action of NUPLAZID is unclear but is thought to be mediated through a combination of inverse agonist and antagonist activity. However, the effect of NUPLAZID could be mediated through a combination of inverse agonist and antagonist activity at serotonin 5-HT2A receptors and to a lesser extent at serotonin 5-HT2C receptors.1
NUPLAZID is proven to reduce delusions and hallucinations associated with PD psychosis in elderly patients1,2
NUPLAZID showed continuous improvement over 6 weeks
Results from a Phase 3, randomized, multicenter, double-blind, placebo-controlled, parallel-group study of PD psychosis patients (N=199).1,2 Primary endpoint was change from baseline at 6 weeks in the 9-item SAPS-PD. Doses of PD medications taken prior to baseline were required to be stable 30 days prior to study start and throughout the study period. Mean baseline score was 15.9 for NUPLAZID and 14.7 for placebo. The mean age of patients enrolled in the clinical study with NUPLAZID was 72 years.2 While the primary endpoint was designed to measure change from baseline to Week 6, a statistically significant difference between NUPLAZID and placebo was observed at Week 4 (P=0.0369) and again at Week 6 (P=0.0014).
LSM=least-squares mean; SAPS-PD=Scale for Assessment of Positive Symptoms-Parkinson’s Disease; SE=standard error.
Treat PD psychosis–related delusions and hallucinations without impacting motor function1,2
NUPLAZID 34 mg did not impact motor function or motoric activities of daily living compared to placebo.*
*As measured by United Parkinson’s Disease Rating Scale Parts II and III (UPDRS II+III).
NUPLAZID has a demonstrated safety profile in elderly patients with PD psychosis1
- In the 6-week studies, 80% of patients in NUPLAZID clinical studies were aged 65 years or older*
No differences in safety were reported based on age, gender, or MMSE score
– 27% of patients had mild cognitive impairment (MMSE 21-24)
- The most 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%)
Important Safety Information for NUPLAZID (pimavanserin)
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
*The maximum age in the clinical studies was 90 years.3
MMSE=Mini-Mental State Examination.
A single-capsule treatment1
- The only FDA-approved therapy proven to reduce delusions and hallucinations associated with PD psychosis in elderly patients without impacting motor function
- In the 6-week studies, 80% of patients were aged 65 years or older*
(Not actual size)
ONE small† capsule
- 34 mg now in one single capsule
ONE daily dose
- Taken orally with or without food
- No dosage adjustment of carbidopa/levodopa is required when administered concomitantly with NUPLAZID
- Avoid the use of NUPLAZID in combination with other drugs known to prolong the QT interval
- For patients taking strong or moderate CYP3A4 inducers, avoid combination use with NUPLAZID
*In the clinical studies, the maximum age of patients on NUPLAZID was 85 years old vs 90 years old for placebo.2
†Actual size is 14.3 mm x 5.3 mm.