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Two recent studies indicate that Nuplazid (pimavanserin) is safe and tolerated well in older or frail adults who experience psychosis linked to Parkinson’s disease.

The drug is the only one currently approved by the US Food and Drug Administration to treat Parkinson’s-associated psychosis.

Data on Nuplazid was presented at this year’s International Congress of Parkinson’s Disease and Movement Disorders, which was held late last month in Philadelphia.

One study found that the drug was well tolerated in most cases. One person had a serious adverse event that investigators thought was related to the drug. 

In the second study, assessment scores related to sleepiness and poor sleep were similar in people on Nuplazid and participants on a placebo. 

Study findings “suggest that pimavanserin may be associated with low levels of sedation and other sleep-related adverse events as well as improvements in nighttime sleep and sleep architecture,” its researchers concluded, recommending further clinical trials.

“These data inform the clinical use of pimavanserin, which is the only FDA-approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis,” Victor Abler, vice president of medical affairs at Acadia Pharmaceuticals, the company that markets the therapy, said in Parkinson’s News Today.

Psychosis is often treated with antipsychotics — usually atypical antipsychotics — made to cause fewer motor-related side effects than traditional antipsychotics. Most antipsychotics affect dopamine levels, which is low in people with Parkinson’s. As a result, other medications can make the symptoms worse, especially if a patient is elderly or frail. 

Nuplazid does not affect dopamine activity. Instead, it targets serotonin receptors called 5HT2A. Earlier research published in the Journal of Alzheimer’s Disease measuring the drug against a placebo found that the drug wasn’t linked to motor or cognitive impairment. Treatment-emergent adverse events and serious events were similar in those on the drug and those not taking it.