INVEGA SUSTENNA® is approved for the treatment of schizoaffective disorder

Recently diagnosed study

In an International* Study vs a Group of 6 Common Oral Antipsychotics in Patients with Recently Diagnosed Schizophrenia, INVEGA SUSTENNA® Demonstrated:

  • The study was not powered to compare the efficacy of INVEGA SUSTENNA® with that of individual oral antipsychotics
  • Percentage of patients who discontinued due to adverse events (AEs) was 4.0% in the INVEGA SUSTENNA® group and 3.0% in the oral antipsychotic group
  • The 5 most common treatment-emergent AEs in the INVEGA SUSTENNA® group were weight increase (15.9%), headache (11.1%), insomnia (9.7%), schizophrenia (8.2%), and nasopharyngitis (7.1%)
  • The 5 most common treatment-emergent adverse events in the oral antipsychotics group were weight increase (17.4%), schizophrenia (9.6%), headache (8.5%), insomnia (8.0%), and suicidal ideation (5.5%).




  • The study was not powered to compare the efficacy of INVEGA SUSTENNA® with that of individual oral antipsychotics
  • The Prevention of Relapse With Oral Antipsychotics Versus Injectable Paliperidone Palmitate (PROSIPAL) study was a multicenter, randomized, prospective, active controlled, open-label, rater-blinded, international 24-month study in recently diagnosed (within 1–5 years) adult patients with schizophrenia (NCT01081769) that was conducted in 141 centers across 26 countries*

Key Inclusion Criteria

  • Age: 18 to 65
  • Acute episode of schizophrenia with Positive and Negative Syndrome Scale (PANSS) total score of 70 to 120 at screening
  • Diagnosis of schizophrenia (DSM-IV®) made 1 to 5 years previously
  • History of ≥2 relapses requiring psychiatric hospitalization within preceding 24 months (may have included the current episode)

Key Exclusion Criteria

  • Antipsychotic naïve
  • Considered by investigator to be treatment resistant or unsuitable for treatment with an atypical oral antipsychotic or oral haloperidol monotherapy
  • Received clozapine within past 3 months
  • Use of LAIs within 3 injection cycles before screening
  • Started a psychotherapy program within 2 months preceding baseline
  • History of current symptoms of tardive dyskinesia
  • History of neuroleptic syndrome
  • Involuntary hospitalization


2-Week Acute Oral Treatment Phase: Patients randomized (1:1) to INVEGA SUSTENNA® or oral treatment arms entered a 2-week initial acute oral treatment phase

  • INVEGA SUSTENNA® arm (n=376): previous oral antipsychotic replaced with oral paliperidone ER (3-12 mg QD)
  • Oral antipsychotic arm (n=388): previous oral antipsychotic replaced with a different oral antipsychotic
    • Percentages of patients receiving oral antipsychotics: aripiprazole (22.3%), paliperidone (21.2%), quetiapine (17.9%), risperidone (15.7%), olanzapine (13.5%), haloperidol (9.4%)
  • Both groups: previous oral antipsychotic was tapered over a maximum of 7 days

24-Month Core Treatment Phase

  • INVEGA SUSTENNA® arm: Dosing was 234 mg intramuscular on Day 1 (deltoid), 156 mg on Day 8 (deltoid), 117 mg on Day 38 (deltoid or gluteal), then once-monthly with flexible dosing of 39 mg to 234 mg (deltoid or gluteal)
  • Oral antipsychotic arm: Continued on the same drug prescribed during the initial 2-week acute oral treatment phase; dosage adjustments were allowed throughout the study

Study Endpoints

Study End Points Chart
  • The study was not powered to compare the efficacy of INVEGA SUSTENNA® with that of individual oral antipsychotics


PANSS=Positive and Negative Syndrome Scale; LAI=long-acting injectable; QD=every day; CGI=Clinical Global Impressions ccale.

*The study was conducted in 26 countries, excluding the United States.

All patients diagnosed 1 to 5 years previously with >2 relapses requiring hospitalization.

Time to relapse was significantly longer in patients treated with INVEGA SUSTENNA® (P=0.019; hazard ratio 1.5; CI=1.1-2.2). 85th percentile for time to relapse was 469 days.

§At 24 months, 52 (14.8%) patients on INVEGA SUSTENNA® experienced a relapse vs 76 (20.9%) in the oral antipsychotic group.

Relapse defined by any of the following: psychiatric hospitalization; increase in the level of psychiatric care and an increase of 25% from baseline in PANSS total score (or an increase of 10 points if baseline score ≤40); deliberate self-injury; suicidal or homicidal ideation; violent behavior resulting in injury to another person or property damage; substantial clinical deterioration; required dose of antipsychotic exceeds the maximum approved dose.

References: 1. Schreiner A, Aadamsoo K, Altamura AC, et al. Paliperidone palmitate versus oral antipsychotics in recently diagnosed schizophrenia. Schiz Res. 2015;169:393-399.

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