From the FDA Drug Label
The efficacy of NUPLAZID 34 mg as a treatment of hallucinations and delusions associated with Parkinson's disease (PD) psychosis was demonstrated in a 6-week, randomized, placebo-controlled, parallel-group study.
The PD-adapted Scale for the Assessment of Positive Symptoms (SAPS-PD) was used to evaluate the efficacy of NUPLAZID 34 mg.
Primary efficacy was evaluated based on change from baseline to Week 6 in SAPS-PD total score
As shown in Table 3, Figure 3, and Figure 4, NUPLAZID 34 mg (n=95) was statistically significantly superior to placebo (n=90) in decreasing the frequency and/or severity of hallucinations and delusions in patients with PDP as measured by central, independent, and blinded raters using the SAPS-PD scale.
An effect was seen on both the hallucinations and delusions components of the SAPS-PD
SAPS-PD Hallucinations‡NUPLAZID 11.1 (4.58)-3.81 (0.46)-2.01 (-3.29, -0.72)
Pimavanserin is effective for treating visual hallucinations in patients with Parkinson's disease psychosis, as demonstrated by a statistically significant decrease in the frequency and/or severity of hallucinations in a 6-week study 1.
- The study used the SAPS-PD scale to evaluate the efficacy of pimavanserin.
- The results showed a significant improvement in hallucinations and delusions components of the SAPS-PD scale.
From the Research
Pimavanserin is a recommended treatment option for visual hallucinations in patients with Parkinson's disease psychosis, with a dosage of 34 mg taken orally once daily, as it has been shown to be effective in reducing hallucinations and delusions without worsening motor symptoms 2.
Key Points
- Pimavanserin works as a selective serotonin 5-HT2A receptor inverse agonist, targeting the neurotransmitter systems involved in hallucinations without blocking dopamine receptors.
- Common side effects include peripheral edema, nausea, and confusion, and patients should be monitored for QT interval prolongation.
- Treatment response should be evaluated within 4-6 weeks, though some patients may respond sooner.
- Pimavanserin should be used cautiously in elderly patients and those with cardiac conditions.
Benefits and Risks
- The medication has been shown to have a lower number of side effects compared to other atypical antipsychotics, and may have a protective effect on the risk of falls in patients with Parkinson's disease 2.
- However, pimavanserin bears a boxed warning about the risk of death associated with antipsychotic use in elderly patients with dementia, and should be used with caution in this population 3.
Clinical Evidence
- A narrative review of pimavanserin for Parkinson's disease psychosis found that the medication was effective in reducing hallucinations and delusions, with a significantly lower number of side effects compared to other atypical antipsychotics 2.
- A phase 3 trial of pimavanserin found that the medication was associated with a significant decrease in SAPS-PD scores, with no significant safety concerns or worsening of motor function 4.