THE SAFETY STORY:

See the results of 6-week placebo-controlled studies1

About NUPLAZID

In the 6-week studies, 80% of patients were aged 65 years or older1

80% of patients were aged 65 years or older

In the 6-week studies, no differences in safety were reported based on age, gender, or MMSE score

  • 27% had mild cognitive impairment (MMSE 21-24)

  • The maximum age in the clinical studies was 90 years2

MMSE=Mini-Mental State Examination.

Safety profile demonstrated in placebo-controlled studies1

Results demonstrated in placebo-controlled studies

*Based on 6-week placebo-controlled studies.

A demonstrated safety profile in elderly patients with Parkinson’s disease (PD) psychosis1

In the 6-week placebo-controlled trials:

zero

 
 

  • No events of neuroleptic malignant syndrome, tardive dyskinesia, or serotonin syndrome were reported with NUPLAZID® (pimavanserin) 34 mg 2,3

eight-percent
  • 8% (n=202) of patients treated with NUPLAZID 34 mg discontinued due to adverse reactions vs 4% (n=231) with placebo1

    • The adverse reactions that occurred in more than one patient and with an incidence of at least twice that of placebo were hallucination (2% NUPLAZID vs <1% placebo), urinary tract infection (1% NUPLAZID vs <1% placebo), and fatigue (1% NUPLAZID vs 0% placebo)

check up

 
 

  • Fewer cases of orthostatic hypotension were reported for NUPLAZID 34 mg compared with placebo (1.0% vs 5.2%)2

 

In September 2018, FDA issued a statement on the benefit-risk profile of NUPLAZID.4 Read the entire statement at FDA.gov

FDA=Food and Drug Administration.

Important Safety Information for NUPLAZID (pimavanserin)

QT Interval Prolongation: NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics. NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.

For healthcare professionals