INVEGA TRINZA® Provides Significant Symptom Improvement in PANSS Total Scores1,2*
Secondary Endpoint: Change in Mean PANSS Total Score Over Time2
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.
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.