Once-Daily NUPLAZID® (pimavanserin) 34 mg Capsule

(Not actual size)*

*Actual size is 14.4 mm x 5.3 mm.

CGI:

Supportive evidence for NUPLAZID efficacy

Once-Daily NUPLAZID® (pimavanserin) 34 mg Capsule

(Not actual size)*

*Actual size is 14.4 mm x 5.3 mm.

Secondary Endpoints: NUPLAZID demonstrated greater improvement in Clinical Global Impressions (CGI) vs placebo1*

CGI-S (Severity) and CGI-I (Improvement) measured over 6 weeks1

CGI-S (Severity) and CGI-I (Improvement) measured over 6 weeksCGI-S (Severity) and CGI-I (Improvement) measured over 6 weeks
  • For the CGI-S, the mean change from baseline (SE) to Week 6 was -1.0 (0.1) for NUPLAZID vs -0.4 (0.1) for placebo.1† A negative change in score indicates improvement2
  • For CGI-I, the results at Week 6 were 2.8 (0.1) for NUPLAZID vs 3.5 (0.1) for placebo.1 A lower score indicates improvement2

A 1-point change in CGI is clinically meaningful.3

Improvement was assessed by investigators who were blinded to SAPS-PD scores. SAPS-PD scores were strongly correlated with CGI scores: Spearman’s rho CGI-S=0.5, CGI-I=0.6.1

Change measured from mean baseline score of 4.3 for NUPLAZID and 4.3 for placebo.1

LSM=least squares mean; SE=standard error.

 
Important Safety Information for NUPLAZID (pimavanserin)
  • Adverse Reactions: The most common adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).


 
For healthcare professionals