Once-Daily NUPLAZID® (pimavanserin) 34 mg Capsule

(Not actual size)*

*Actual size is 14.4 mm x 5.3 mm.

Long-Term Safety Findings:

Results from an open-label safety study

Once-Daily NUPLAZID® (pimavanserin) 34 mg Capsule

(Not actual size)*

*Actual size is 14.4 mm x 5.3 mm.

More Than Half of Enrolled Subjects Remained in the Open-Label Extension Study Longer Than a Year, ChartMore Than Half of Enrolled Subjects Remained in the Open-Label Extension Study Longer Than a Year, Chart

No new or unexpected safety findings were observed in patients receiving NUPLAZID in an OLE study1

 

  • The types of adverse events reported in an OLE study were comparable to the 6-week, placebo-controlled studies1
  • 19.2% of patients (n=88) discontinued study due to adverse events1

Patient discontinuation and treatment-emergent adverse events in open-label extension safety study

Termination Reason Recorded in ≥10% of Patients (N=459)1*
Primary Reason Overall, n (%)
Voluntary withdrawal of consent 167 (36.4)
Adverse event 88 (19.2)
Sponsor decision 55 (12.0)
Disease progression 46 (10.0)

*Other reasons for termination (<10%) included death, investigator decision, subject non-compliance, and lost to follow up.

Treatment-Emergent Adverse Events Occurring in ≥10% of Patients (N=459)1
Adverse Event Number (%) of Patients
Fall 147 (32.0)
Urinary tract infection 87 (19.0)
Hallucination 63 (13.7)
Weight decreased 57 (12.4)
Confusional state 51 (11.1)
Constipation 47 (10.2)

Important Note: The results of this OLE safety study should be interpreted with the following limitations: open-label design, lack of control arm, inability to assess patients long-term after discontinuation, and high discontinuation rate due to various reasons over >4 years of the study duration. This could represent chance findings.

For healthcare professionals