INVEGA TRINZA® Provides Significant Symptom Improvement in PANSS Total Scores1,2*

Secondary Endpoint: Change in Mean PANSS Total Score Over Time2

secondary-endpoint

PANSS=Positive and Negative Syndrome Scale.

*Population included adults diagnosed within 5 years of study entry.

Indicated for the treatment of schizophrenia in adult patients after they have been adequately treated with INVEGA SUSTENNA® (1-month paliperidone palmitate) for at least four months.

The full constellation of symptoms and the relevant diagnostic criteria should be consulted and are available in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV®, or current version), where applicable.

Study Design

A randomized, double-blind, placebo-controlled, long-term maintenance study compared 3-month paliperidone palmitate (INVEGA TRINZA®) with placebo in adult patients with schizophrenia. Patients were treated for 17 weeks with 1-month paliperidone palmitate (INVEGA SUSTENNA®) during an open-label, flexible-dose stabilization phase, and then a single dose of INVEGA TRINZA® during an open-label maintenance phase. This was followed by a fixed dose of INVEGA TRINZA® or placebo once every 3 months in a variable-duration, double-blind phase. A preplanned interim analysis conducted by an Independent Data Monitoring Committee after 42 relapse events resulted in the decision to terminate the study early due to significant efficacy favoring INVEGA TRINZA®. The secondary endpoint of PANSS total score is based on final analysis.1,2

References: 1. Berwaerts J, Liu Y, Gopal S, et al. Efficacy and safety of the 3-month formulation of paliperidone palmitate vs placebo for relapse prevention of schizophrenia: a randomized clinical trial. JAMA Psychiatry. 2015;72(8):830-839. Supplemental data available at: http://archpsyc.jamanetwork.com/article.aspx?articleid=2211343#tab12. Accessed November 8, 2019. 2. INVEGA TRINZA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; January 2019.