FOR US HEALTHCARE PROFESSIONALS ONLY
Primary endpoint
At Week 48*
of patients taking
INVEGA TRINZA®
VS
of patients taking
INVEGA SUSTENNA®
remained relapse-free1
Secondary endpoint
Mean PANSS total scores were similar for INVEGA SUSTENNA® and INVEGA TRINZA® over time during the double-blind phase1
Nearly 60% of patients in both groups demonstrated symptomatic remission† during the last 6 months of the double-blind phase1‡
PANSS=Positive and Negative Syndrome Scale.
*Results of a 48-week, randomized, double-blind noninferiority trial. The prespecified noninferiority margin was -15%. After screening (< 3 weeks) and a 17-week, open-label phase of treatment with INVEGA SUSTENNA®, clinically stable patients were randomized (1:1) to treatment with INVEGA SUSTENNA® or INVEGA TRINZA® for a 48-week double-blind phase. Based on changes from double-blind baseline.
†With one excursion allowed.
‡Symptomatic remission was defined by the Andreasen remission criteria.1 These criteria were developed by an expert working group who reviewed available definitions and assessment instruments to provide a conceptual framework for symptomatic, functional, and cognitive domains in schizophrenia as they relate to remission of illness. The Andreasen criteria are taken from individual scores from all 3 domains of the PANSS, in order to provide a global definition of remission.2
Primary endpoint: time to first relapse
Occurrence of 1 or more of the following:
PANSS=Positive and Negative Syndrome Scale.
Secondary endpoint: change in mean PANSS total score over time
PANSS=Positive and Negative Syndrome Scale.
*Defined as PANSS total score < 70, PANSS item [P1, P2, P3, P6, P7, G8, G14] scores ≤4, and reduction in Clinical Global Impression-Severity (CGI-S) score by ≥1 from open-label baseline.
Nearly 6 out of 10 patients in both the INVEGA TRINZA® and INVEGA SUSTENNA® arms showed symptomatic remission*
*With one excursion allowed.
*The 5 doses included the 2 initiation doses and 3 maintenance doses.
†Patients successfully stabilized on INVEGA SUSTENNA® were randomized to continue receiving INVEGA SUSTENNA® or to transition to INVEGA TRINZA®.
DSM-IV=Diagnostic and Statistical Manual of Mental Disorders, 4th ed.
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