THE EFFICACY STORY:
The only FDA-approved therapy proven to reduce delusions and hallucinations associated with PD psychosis without impacting motor function1,2
The only FDA-approved therapy proven to reduce delusions and hallucinations associated with PD psychosis in elderly patient without impacting motor function1,2*
*As measured by United Parkinson’s Disease Rating Scale Parts II and III (UPDRS II+III).
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.
At Week 6, NUPLAZID decreased1,4:
- Delusions by 41% compared with 21% for placebo—a -1.95 point change from baseline vs -1.01 for placebo*
- Hallucinations by 34% compared with 18% for placebo—a -3.81 point change from baseline vs -1.80 for placebo†
Complete resolution of symptoms is possible with NUPLAZID 34 mg1
- ~14% of patients had a complete response‡ with NUPLAZID vs 1% with placebo
26.3% of patients treated with NUPLAZID 34 mg experienced a worsening of, or no change in, the SAPS-PD, compared with 44.4% of placebo-treated patients.1
*Exploratory analysis: change measured from mean baseline score of 4. 8 for NUPLAZID and placebo.4
†Exploratory analysis: change measured from mean baseline score of 11.1 for NUPLAZID and 10.0 for placebo.4
‡Complete response: SAPS-PD score reduced to zero from baseline value.1
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%).
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
*As measured by Unified Parkinson's Disease Rating Scale Parts II and III (UPDRS II+III).
†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.