(Not actual size)*
*Actual size is 14.4 mm x 5.3 mm.
OPEN-LABEL EXTENSION STUDY:
Sustained results over 10 weeks
(Not actual size)*
NUPLAZID efficacy results were sustained, with reductions in the frequency and/or severity of hallucinations and delusions continued from Week 6 through Week 10 in an open-label extension (OLE) of the study1*†
SAPS-PD change from core-baseline by visit1
Of the 199 participants entering the Phase 3, 6-week, placebo-controlled study, 176 completed the 6-week study, and 171 entered the open-label extension (OLE) study. All patients received NUPLAZID 34 mg at Week 6 (baseline OLE) of the 10‑week treatment period.1,2
The 10-week treatment period includes 6 weeks of the placebo-controlled study plus the first 4 weeks of the OLE study. During the first 4 weeks of the OLE, patients and investigators remained blinded to the original treatment allocation from the placebo-controlled phase.1
Mean (SD) SAPS-PD scores at core baseline were 14.4 (5.4) for the placebo-to-NUPLAZID group and 16.0 (6.1) for the NUPLAZID-to-NUPLAZID group; mean change (SE) in SAPS-PD from core baseline to Week 10 were -6.28 (1.0) and -6.86 (0.8), respectively. In total, 148 (87%) patients completed Week 10 assessments in the OLE.1
Mean change (SE) for the SAPS-PD score from Week 6 (OLE baseline) to Week 10 (OLE Week 4) was -3.43 (0.73) among patients who received placebo in the phase 3 study, and -0.43 (0.79) for patients who received NUPLAZID.1
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.