(Not actual size)*
*Actual size is 14.4 mm x 5.3 mm.
THE EFFICACY STORY:
The only FDA-approved therapy proven to reduce the frequency and/or severity of hallucinations and delusions associated with PD psychosis without impacting motor function1,2
(Not actual size)*
NUPLAZID significantly reduced the frequency and/or severity of hallucinations and delusions associated with PD psychosis at 6 weeks vs placebo (Primary Endpoint)1
NUPLAZID showed signs of improvement from baseline as early as 2 weeks, with significant reductions at Weeks 4 & 61,2
Results from a Phase 3, randomized, multicenter, double-blind, placebo-controlled, parallel-group study of patients with PD psychosis (N=199). Primary endpoint was change from baseline in the 9-item SAPS-PD. PD medications were required to be stable for at least 30 days prior to study entry and throughout the study period. Mean baseline score was 15.9 for NUPLAZID and 14.7 for placebo.1,2 The mean age of patients enrolled in the clinical study with NUPLAZID was 72 years. 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).2
LSM=least squares mean; SAPS=Scale for Assessment of Positive Symptoms; SE=standard error.
Limit PD psychosis, not your patients
- UPDRS II+III is a clinical rating scale that assesses motor function and its impact on activities of daily living
- The UPDRS score was calculated as the sum of the 40 items from activities of daily living and motor examination, with a range of 0 to 160
- A negative change in score indicates improvement
Secondary endpoint as measured by Unified Parkinson's Disease Rating Scale Parts II and III (UPDRS II+III). Mean UPDRS II+III baseline score was 51.5 for NUPLAZID and 52.6 for placebo.2
Difference (drug minus placebo) in LSM.
Noninferiority criteria required that the upper bound of the 95% CI not exceed 5.
CI=confidence interval; LSM=least-squares mean.
Important Safety Information for NUPLAZID (pimavanserin)
- Adverse Reactions: 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%).