INVEGA SUSTENNA® is approved for the treatment of schizoaffective disorder

90% of INVEGA SUSTENNA® Patients Remained Relapse-Free at the Interim Analysis of a Longer-term Study1

In schizophrenia: Significantly longer time to relapse vs placebo (P<0.0001)1,2
A graph illustrating the clinical data about INVEGA SUSTENNA® efficacy concerning time to relapse for patients

*Median time to relapse for placebo group was 163 days.1

  • Due to the significant efficacy of INVEGA SUSTENNA®, the study was terminated early at the preplanned interim analysis by an Independent Data Monitoring Committee1

Relapse criteria

In this study, relapse was defined as experiencing ≥1 of the following1,2:

  • Psychiatric hospitalization
  • 25% increase in PANSS total score
  • Increase in individual PANSS item scores
  • Deliberate self-injury, violent behavior
  • Suicidal or homicidal ideation

This study was not powered to draw conclusions for individual reasons for relapse.

PANSS=Positive and Negative Syndrome Scale.

Defined as a 10-point increase (if the baseline score was ≤40) or ≥25% increase (if the baseline score was >40) in PANSS total score on 2 consecutive assessments.1,2

Defined as a score of ≥5 (if the maximum baseline score was ≤3) or ≥6 (if the maximum baseline score was 4) on 2 consecutive assessments of individual PANSS items: P1 (delusions), P2 (conceptual disorganization), P3 (hallucinatory behavior), P6 (suspiciousness/persecution), P7 (hostility), or G8 (uncooperativeness).1,2

Established Efficacy in Maintaining Schizophrenia Symptom Control in a Longer-term Study1,2

Abbreviated study design1,2
A diagram illustrating an abbreviated visual of INVEGA SUSTENNA® efficacy, study design
  • Median duration of total exposure in the INVEGA SUSTENNA® arm was 13 months1
  • Due to significant efficacy of INVEGA SUSTENNA®, the study was stopped early after the preplanned interim analysis by an Independent Data Monitoring Committee1
  • The median time to relapse in the placebo arm of the double-blind phase was 163 days1
  • 36% of adults were diagnosed within 5 years, with a mean age of 33 years (the mean age of all patients in the study was 39 years [n=408])2,3

In this study, relapse was defined as experiencing ≥1 of the following1,2:

  • Psychiatric hospitalization
  • ≥25% increase in PANSS total score§
  • Increase in individual PANSS item scores||
  • Deliberate self-injury, violent behavior
  • Suicidal or homicidal ideation

This study was not powered to draw conclusions for individual reasons for relapse.

PANSS=Positive and Negative Syndrome Scale.

§Defined as a 10-point increase (if the baseline score was ≤40) or ≥25% increase (if the baseline score was >40) in PANSS total score on 2 consecutive assessments.1,2

||Defined as a score of ≥5 (if the maximum baseline score was ≤3) or ≥6 (if the maximum baseline score was 4) on 2 consecutive assessments of individual PANSS items: P1 (delusions), P2 (conceptual disorganization), P3 (hallucinatory behavior), P6 (suspiciousness/persecution), P7 (hostility), or G8 (uncooperativeness).1,2

 

References: 1. INVEGA SUSTENNA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; March 2018. 2. Hough D, Gopal S, Vijapurkar U, Lim P, Morozova M, Eerdekens M. Paliperidone palmitate maintenance treatment in delaying the time-to-relapse in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. Schizophr Res. 2010;116(2-3):107-117. 3. Data on file. Janssen Pharmaceuticals, Inc., Titusville, NJ.  

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