About NUPLAZID® (pimavanserin), Banner

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Start patients on NUPLAZID®—the only FDA-approved treatment indicated for hallucinations and delusions associated with PD psychosis1,2

Once-Daily NUPLAZID® (pimavanserin) 34 mg Capsule

(Not actual size)

ONE FDA-approved treatment, ONE small* capsule, ONE daily dose

  • Proven to reduce the frequency and/or severity of hallucinations and delusions associated with PD psychosis1
  • Demonstrated safety and tolerability profile for patients with PD psychosis1
  • Recognized as clinically useful for the treatment of PD psychosis by the Movement Disorder Society3

*Actual size is 14.3 mm X 5.3 mm.

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 & 61,4

NUPLAZID® (pimavanserin) Efficacy, GraphNUPLAZID® (pimavanserin) Efficacy, Graph

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.1,4 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).4

LSM=least squares mean; SAPS=Scale for Assessment of Positive Symptoms; SE=standard error.

NUPLAZID® (pimavanserin) 34mg Did Not Impact Motor Function, Icon

Treat PD psychosis–related hallucinations and delusions without impacting motor function1,4

NUPLAZID worked without impacting motor function or motoric activities of daily living vs placebo at Week 6.*

Mean change from baseline*: NUPLAZID -1.4 (n=92) vs placebo -1.7 (n=88). (Placebo-subtracted difference [95% CI] 0.3 [-2.1, 2.7].)

Secondary endpoint as measured by Unified Parkinson’s Disease Rating Scale Parts II and III. Mean UPDRS Parts II+III baseline score was 51.5 for NUPLAZID and 52.6 for placebo.4

Noninferiority criteria required that the upper bound of the 95% CI not exceed 5.

NUPLAZID has a demonstrated safety profile in elderly patients with PD psychosis1

NUPLAZID 34 mg-Demonstrated Safety Profile Proven in Elderly Patients with PD Psychosis
  • 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 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%)

In the clinical studies, the maximum age of patients on NUPLAZID was 85 years old vs 90 years old for placebo.5

MMSE=Mini-Mental State Examination.

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

A single-capsule treatment1

FDA Approved

ONE treatment

  • The only FDA-approved therapy proven to reduce the frequency and/or severity of hallucinations and delusions 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*

In the clinical studies, the maximum age of patients on NUPLAZID was 85 years old vs 90 years old for placebo.5

Once-Daily NUPLAZID® (pimavanserin) 34 mg Capsule

(Not actual size)

ONE small capsule

  • 34 mg in one single capsule

Actual size is 14.3 mm x 5.3 mm.

One Daily Dose

ONE daily dose

  • Taken orally with or without food, without titration
    • 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 CYP3A4 inhibitors, the recommended dose of NUPLAZID is 10 mg once daily
    • Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID

 

For healthcare professionals