Efficacy

93% of patients remained relapse-free in a long-term maintenance trial1

 

Significantly longer time to relapse vs placebo (P<0.001)1,2

Efficacy
 
  • 7% of patients taking INVEGA TRINZA® relapsed vs 23% of patients taking placebo (P<0.001)1,2
  • Median time to relapse in the placebo arm of the double-blind phase was 274 days1,2
  • Median time to relapse in the INVEGA TRINZA® arm could not be estimated due to the low percentage (7.4%) of subjects with relapse1,2
  • Due to the significant efficacy of INVEGA TRINZA®, the study was terminated early at the preplanned interim analysis by an Independent Data Monitoring Committee1,2

Following stabilization with INVEGA SUSTENNA® (paliperidone palmitate), all patients received 1 dose of INVEGA TRINZA® 12 weeks before randomization in the double-blind phase of the clinical trial.1

Key study observations1,2:

  • Median time to relapse in the placebo arm of the double-blind phase was 274 days
  • Median time to relapse in the INVEGA TRINZA® arm could not be estimated due to the low percentage (7.4%) of subjects with relapse

Study design: A randomized, double-blind, placebo-controlled, long-term maintenance study compared 3-month paliperidone palmitate (INVEGA TRINZA®) to 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®.1,2

See further details about the study design >>

Key inclusion criteria1,2:

  • Adult patients (aged 18 to 70 years) with a diagnosis of schizophrenia* for ≥1 year before screening
  • PANSS total score <120 at screening and baseline
  • Patients with acute symptoms (if previously treated with oral antipsychotics) or who were clinically stable (if treated with long-acting injectable antipsychotics)

Key exclusion criteria2:

  • Primary, active DSM-IV® diagnosis other than schizophrenia
  • Significant risk of suicidal behavior
  • History of substance dependence within 6 months before screening
  • Involuntary status in a psychiatric hospital at screening
  • History of neuroleptic malignant syndrome, tardive dyskinesia, or any malignancy in the previous 5 years, except basal cell carcinoma
Approved for the treatment of schizophrenia

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-5®, or current version), where applicable.1,2

*

Based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV-TR®) criteria.2
PANSS=Positive and Negative Syndrome Scale.

 

Relapse was defined as emergence of ≥1 of the following1,2:

  • Psychiatric hospitalization
  • ≥25% increase in PANSS total score
  • Increase in distinct PANSS item scores
  • Deliberate self-injury or violent behavior
  • Suicidal or homicidal ideation
Approved for the treatment of schizophrenia

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-5®, or current version), where applicable.1,2

Defined as a ≥25% increase for 2 consecutive assessments between 3 and 7 days apart for patients scoring >40 at randomization or a 10-point increase for patients scoring ≤40 at randomization.1,2

 

You can prescribe INVEGA TRINZA® knowing that 9 out of 10 patients did not relapse at the completion of the long-term maintenance study1


Change in mean PANSS total score over time2

PANSS=Positive and Negative Syndrome Scale.

References: 1. INVEGA TRINZA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; March 2016. 2. 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 March 28, 2016.