According to a recent article in Parkinson’s News Today, results of an extension study confirm that FDA approved Nuplazid (pimavanserin) reduces the severity of delusions and hallucinations in Parkinson’s disease psychosis (PDP).
Psychosis, experienced by fifty percent of Parkinson’s patients, is one of the non-motor symptoms associated with the disease.
Nuplazid blocks 5HT2A serotonin receptors (chemical structures) that are associated with schizophrenia, depression, and psychosis.
Nuplazid is marketed through Acadia Pharmaceuticals and was approved based on the NCT01174004 Phase III study. The study enrolled 199 patients with Parkinson’s psychosis who were assigned 34 mg of Nuplazid or a placebo. The medication was to be taken once daily for a six-week period.
Results of the study showed a reduction in the frequency of delusions and hallucinations compared to the placebo. The results also confirmed that motor symptoms were not affected.
About NCT00550238
Patients who had participated in earlier Nuplazid trials were able to participate in an extension trial and could receive Nuplazid for four weeks.
Results from the assessment of 171 patients involved in the original Phase III trial were presented at the 2020 annual ASCP convention. Of the 171 patients who then entered the extension study (NCT00550238), a total of 148 people completed that study.
Patients who completed the entire ten weeks as well as patients who only participated in the second study for four weeks experienced significant benefits.
Patients who had received the placebo but were included in the second study were found to have benefited only fifty percent in relation to the ten-week cohort.
The patients were also assessed by CGI-S and CGI-I. In this assessment, the placebo cohort showed a significant improvement. Almost half of the group expressed significant improvement while after four weeks of taking Nuplazid over fifty-seven percent felt that they had significantly improved.
About Adverse Events (AEs)
The AEs found in the second study were mild to moderate in their severity. They were similar to the AEs reported in the first study. The most frequently reported AEs were hallucinations, infections in the urinary tract, swelling, and accidental falls. Fourteen patients had side effects causing treatment discontinuance.
The participating researchers reported significant improvement in the patients with psychotic symptoms who received 34mg each day for ten weeks.
Arcadia presented additional safety data on Nuplazid at the ASCP meeting. New findings were also reported from other trials assessing people with central nervous system disorders in the spinal cord and brain as well as schizophrenia and depressive disorders.
Arcadia’s president emphasized Nuplazid’s role as a critical treatment option in depressive disorders and schizophrenia. The drug has also exhibited tolerability and safety when administered to Parkinson’s patients who are experiencing psychosis.
