Study Results Show Lower Mortality Risk With Nuplazid for Parkinson Disease Psychosis


Analysis indicates that Acadia Pharmaceuticals Inc’s pimavanserin is the only FDA-approved medication for the treatment of delusions and hallucinations associated with PDP.

There is a lower mortality risk in individuals with Parkinson disease psychosis (PDP) treated with pimavanserin (Nuplazid; Acadia Pharmaceuticals Inc) compared with other atypical antipsychotics over 12 months across various subgroups, according to the results of a retrospective analysis published in Drug Safety.

Pimavanserin is the only FDA-approved medication for the treatment of delusions and hallucinations are associated with PDP. It is a selective serotonin inverse agonist and antagonist, preferentially targeting 5-HT2a receptors, which are suspected to play an important role in neuropsychiatric disorders.

“We were encouraged by this large, real-world study showing a lower mortality risk in patients with PDP after initiation of [pimavanserin] compared to other atypical antipsychotics. The robust results were achieved across sub-groups and sensitivity analysis using a variety of approaches,” Ponni Subbiah, MD, MPh, senior vice president, global head of Medical Affairs and chief medical officer at Acadia Pharmaceuticals, said in a statement.

“These findings, along with other recently published studies, will help physicians and the patients they treat make decisions about managing [PDP) symptoms that can be quite troubling and disruptive to patients and their families, significantly impacting their quality of life,” she said.

The observational, real-world study was used to evaluate a cohort of individuals identified using 2016 through 2019 Medicare claims for those aged 65 years or older in the United States who were diagnosed with Parkinson disease and psychosis. Investigators compared individuals who newly started pimavanserin or were prescribed an off-label comparator atypical antipsychotic, such as aripiprazole, brexpiprazole, clozapine, olanzapine, quetiapine, or risperidone.

After matching the cohorts with propensity scores, investigators included 2891 individuals in both the pimavanserin and comparator cohorts. In the matched cohorts, the hazard ratio (HR) for all-cause mortality for pimavanserin compared with the comparator was 0.78, with the lowest time period-specific HRs in the first 180 days.

Additionally, investigators used a sub-cohort of 30% of individuals in long-term care (LTC) or skilled nursing facilities (SNF), which were matched at 653 individuals for the pimavanserin and comparator cohorts.

They found that the HR was also 0.78.

When mortality was evaluated separately within the subgroups. The HR estimates were consistent across age, dementia diagnosis, and sex.

The analysis was observed over approximately 3.5 years after the FDA approval and subsequent availability in the United States. During the early period, patient characteristics may have differed between both groups. Although matching balanced the measured characteristics, unmeasured characteristics could have contributed for the results.

Furthermore, the LTC/SNF sub-cohort analysis was limited by the small sample size.

Pimavanserin was approved for the treatment of delusions and hallucination associated with PDP in April 2016. The company continues to develop pimavanserin for other neuropsychiatric conditions.

The common adverse events for pimavanserin include confusional states, constipation, gait disturbance, hallucination, nausea, and peripheral edema.


Newly published retrospective analysis showed lower all-cause mortality risk among Parkinson’s disease psychosis patients treated with Nuplazid (pimavanserin) compared to those treated with other atypical antipsychotics. Business Wire. News release. January 3, 2023. Accessed January 10, 2023.

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