INVEGA SUSTENNA® Demonstrated Efficacy in Both Short-term and Long-term Studies

In a Longer-term Study, INVEGA SUSTENNA® Demonstrated Significantly longer time to relapse vs placebo (P<0.0001)1,2

pivotal study overview
  • Due to the significant efficacy of INVEGA SUSTENNA®, the study was terminated early at the preplanned interim analysis by an Independent Data Monitoring Committee1
  • The most common adverse reactions from the 5 pivotal trials (incidence ≥5% and occurring at least twice the rate of placebo) were injection-site reactions, somnolence/sedation, dizziness, akathisia, and extrapyramidal disorder1

Relapse Criteria

In the longer-term 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.

Indicated for the treatment of schizophrenia in adults.

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.

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

†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

Secondary Endpoint: Change in Mean PANSS Total Score Over Time2

pivotal study secondary endpoint

Mean PANSS total score* remained stable for patients on INVEGA SUSTENNA® while significantly worsening for patients on placebo during a longer-term study.2†

Abbreviated Long-term Study Design2

pivotal study abbreviated study design
  • Results from the longer-term, placebo-controlled study of adult patients with schizophrenia. Patients were treated for 33 weeks during an open-label stabilization phase with INVEGA SUSTENNA® (39 mg, 78 mg, or 156 mg every 4 weeks after initialization)
  • Patients were then randomized to this same dose or to placebo in a variable-length, double-blind phase. A preplanned interim analysis was conducted after 68 relapse events1,2

Long-term Study Notes

  • Median duration of total exposure in the INVEGA SUSTENNA® (paliperidone palmitate) arm was 13 months2
  • Due to significant efficacy of INVEGA SUSTENNA®, the study was stopped early after the preplanned interim analysis by an Independent Data Monitoring Committee1,2
  • The median time to relapse in the placebo arm of the double-blind phase was 163 days
  • 36% of adults were diagnosed within 5 years, with a mean age of 33 years (the mean age of all the patients in the study was 39 years [n=408])2,3

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

†Medium duration of total exposure in the INVEGA SUSTENNA® arm was 13 months.

A Short-term Study Demonstrated Significant Symptom Improvement in PANSS Total Scores1,3

pivotal study panss scores
  • Doses were administered on Day 1 (234 mg) and Days 8, 36, and 64 (per dosage strength in study design)
  • NOTE: Two deltoid intramuscular injections of 234 mg (on Day 1) and 156 mg (on Day 8) are the recommended initiation doses for INVEGA SUSTENNA®

Demonstrated Change in PANSS Subscales4

pivotal study panss subscales

INVEGA SUSTENNA® demonstrated significant symptom improvement in PANSS total scores1,4*

  • The study was not powered to draw conclusions for individual factors of the PANSS

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

Short-term Study Design

Results from a double-blind, randomized, placebo-controlled, fixed-dose, 13-week study of adult patients experiencing an acute exacerbation of schizophrenia. Patients were randomized to receive placebo or a 234-mg deltoid injection dose on Day 1, followed by a 39-mg, 156-mg, or 234-mg dose in either the deltoid or gluteal muscle on Day 8, and once monthly thereafter.1,4

PANSS Subscales1,5:

The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale that measures positive and negative symptoms of schizophrenia, as well as general psychopathology.1,5 The PANSS subscales can be used to assess symptom changes.5

  • 7-item positive scale, measuring symptoms added to normal mental status5
  • 7-item negative scale, assessing features absent from normal mental status5
  • 16-item general psychopathology scale, measuring the overall severity of schizophrenia5

Positive Scale

  • Delusions
  • Conceptual disorganization
  • Hallucinatory behavior
  • Excitement
  • Grandiosity
  • Suspiciousness
  • Hostility

Negative Scale

  • Blunted affect
  • Emotional withdrawal
  • Poor rapport
  • Passive-apathetic social withdrawal
  • Difficulty in abstract thinking
  • Lack of spontanaeity and flow of conversation
  • Stereotyped thinking

General Psychopathology Scale

  • Somatic concern
  • Anxiety
  • Guilt feelings
  • Tension
  • Mannerisms and posturing
  • Depression
  • Motor retardation
  • Uncooperativeness
  • Unusual thought content
  • Disorientation
  • Poor attention
  • Lack of judgment and insight
  • Disturbance of volition
  • Poor impulse control
  • Preoccupation
  • Active social avoidance

PANSS=Positive and Negative Syndrome Scale

References: 1. INVEGA SUSTENNA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; January 2019. 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. 4. Pandina GJ, Lindenmayer JP, Lull J, et al. A randomized, placebo-controlled study to assess the efficacy and safety of 3 doses of paliperidone palmitate in adults with acutely exacerbated schizophrenia. J Clin Psychopharmacol. 2010;30(3):235-244. 5. Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-276.